Kvalitetstekniker - Lediga jobb

Som kvalitetsingenjör på Fergas får du en bred och verksamhetsnära roll med stort fokus på förbättringsarbete, kunddialog och kvalitetssäkring genom hela värdekedjan. En viktig del av uppdraget är att minska gapet mellan produktion, konstruktion och kvalitet, och säkerställa att vi arbetar strukturerat, förebyggande och med rätt fokus.

Du kommer arbeta med avvikelsehantering, kundreklamationer och grundorsaksanalyser - vilket utgör en central del av rollen. Samtidigt är du med och driver förbättringar i produktion och verksamhet, där du både utmanar och stöttar organisationen i kvalitetsfrågor. I rollen ingår även att arbeta med och utveckla ledningssystem enligt ISO-standarder, delta i FMEA-arbete samt bidra till vårt hållbarhetsarbete, exempelvis kopplat till leverantörsdata och kemikaliehantering. På sikt finns också möjlighet att vara med och utveckla arbetssätt kring livscykelanalys.

Rollen rör sig i gränslandet mellan produktion och produktutveckling. Du behöver inte äga alla delar men du behöver förstå helheten, ställa rätt frågor och driva arbetet framåt. Du kommer arbeta nära flera funktioner, inte minst produktionsteknik, konstruktion och inköp.

• Driva och följa upp avvikelsehantering samt genomföra grundorsaksanalyser

• Hantera kundreklamationer och bidra i dialogen med både kunder och leverantörer

• Identifiera och driva förbättringsinitiativ i produktion och verksamhet

• Stötta organisationen i kvalitetsfrågor genom struktur, arbetssätt och utbildning

• Arbeta med och vidareutveckla ledningssystem samt delta i interna revisioner

• Medverka i FMEA-arbete och kvalitetssäkring i både produktion och utveckling

Vi tror att du har några års erfarenhet inom kvalitet i en industriell miljö, och att du är trygg i att driva frågor framåt, även när det kräver tydlighet och struktur.

Du behöver inte kunna allt från start. Det viktiga är att du har rätt grund, rätt inställning och en vilja att utvecklas tillsammans med oss.

Vi ser gärna att du har:

• Civil- eller högskoleingenjörsutbildning

• Erfarenhet av kvalitetsarbete inom industri

• God förståelse för ISO9001 och ISO14001

• Erfarenhet av avvikelsehantering eller grundorsaksanalyser

• Vana att arbeta med kunder eller leverantörer i kvalitetsfrågor

Det är meriterande om du har erfarenhet av exempelvis IATF16949, FMEA, statistiska metoder eller LEAN, samt ett intresse för produktions- eller produktutveckling ur ett kvalitetsperspektiv.

För att lyckas i rollen behöver du kombinera struktur med genomförandekraft. Du är inte rädd för att ställa krav, men gör det på ett sätt som får med dig organisationen. Du är tydlig, kommunikativ och har en förmåga att engagera andra, samtidigt som du är principfast och vågar stå på dig när det behövs.

Du gillar att göra saker bättre – på riktigt.

Här får du en central roll i verksamhetens utveckling, där du arbetar nära både teknik, produktion och kund. Du får möjlighet att påverka arbetssätt och struktur, samtidigt som du blir en del av ett bolag med tydlig ambition att utvecklas och bli bättre.

I den här rekryteringen samarbetar Fergas tillsammans med Skill Rekrytering och Bemanning. Om du går vidare kommer du därefter att få ett mejl med en länk till våra arbetspsykologiska tester som på ett objektivt sätt hjälper oss att matcha rätt person till tjänsten. Vid frågor om tjänsten eller rekryteringsprocessen, vänligen kontakta ansvarig rekryterare Anna-Stina Pantzare på anna-stina.panztare@skill.se.

Med anledning av semesterperiod kommer vi att återkoppla på din ansökan efter v.32.

Vi ser fram emot din ansökan!

Fergas Group är en verkstadskoncern med huvudkontor i Linköping, där bolaget grundades för över 75 år sedan. Vi utvecklar, producerar och säljer fläktar och fläktsystem till en lång rad olika applikationer – från ventilation och uppvärmning till vitvaror och fordonsindustrin.

Koncernen har tillverkningsenheter i Sverige, Italien och Kina samt säljkontor i USA, Brasilien och Indien. Vi är cirka 150 medarbetare globalt och arbetar under devisen “Your Global Partner in Air Moving Solutions”.

Hos oss får du arbeta i en verksamhet med korta beslutsvägar, stort eget ansvar och nära samarbete mellan teknik, produktion och affär.

#LI-DNI

Som kvalitetsingenjör på Fergas får du en bred och verksamhetsnära roll med stort fokus på förbättringsarbete, kunddialog och kvalitetssäkring genom hela värdekedjan. En viktig del av uppdraget är att minska gapet mellan produktion, konstruktion och kvalitet, och säkerställa att vi arbetar strukturerat, förebyggande och med rätt fokus.

Du kommer arbeta med avvikelsehantering, kundreklamationer och grundorsaksanalyser - vilket utgör en central del av rollen. Samtidigt är du med och driver förbättringar i produktion och verksamhet, där du både utmanar och stöttar organisationen i kvalitetsfrågor. I rollen ingår även att arbeta med och utveckla ledningssystem enligt ISO-standarder, delta i FMEA-arbete samt bidra till vårt hållbarhetsarbete, exempelvis kopplat till leverantörsdata och kemikaliehantering. På sikt finns också möjlighet att vara med och utveckla arbetssätt kring livscykelanalys.

Rollen rör sig i gränslandet mellan produktion och produktutveckling. Du behöver inte äga alla delar men du behöver förstå helheten, ställa rätt frågor och driva arbetet framåt. Du kommer arbeta nära flera funktioner, inte minst produktionsteknik, konstruktion och inköp.

• Driva och följa upp avvikelsehantering samt genomföra grundorsaksanalyser

• Hantera kundreklamationer och bidra i dialogen med både kunder och leverantörer

• Identifiera och driva förbättringsinitiativ i produktion och verksamhet

• Stötta organisationen i kvalitetsfrågor genom struktur, arbetssätt och utbildning

• Arbeta med och vidareutveckla ledningssystem samt delta i interna revisioner

• Medverka i FMEA-arbete och kvalitetssäkring i både produktion och utveckling

Vi tror att du har några års erfarenhet inom kvalitet i en industriell miljö, och att du är trygg i att driva frågor framåt, även när det kräver tydlighet och struktur.

Du behöver inte kunna allt från start. Det viktiga är att du har rätt grund, rätt inställning och en vilja att utvecklas tillsammans med oss.

Vi ser gärna att du har:

• Civil- eller högskoleingenjörsutbildning

• Erfarenhet av kvalitetsarbete inom industri

• God förståelse för ISO9001 och ISO14001

• Erfarenhet av avvikelsehantering eller grundorsaksanalyser

• Vana att arbeta med kunder eller leverantörer i kvalitetsfrågor

Det är meriterande om du har erfarenhet av exempelvis IATF16949, FMEA, statistiska metoder eller LEAN, samt ett intresse för produktions- eller produktutveckling ur ett kvalitetsperspektiv.

För att lyckas i rollen behöver du kombinera struktur med genomförandekraft. Du är inte rädd för att ställa krav, men gör det på ett sätt som får med dig organisationen. Du är tydlig, kommunikativ och har en förmåga att engagera andra, samtidigt som du är principfast och vågar stå på dig när det behövs.

Du gillar att göra saker bättre – på riktigt.

Här får du en central roll i verksamhetens utveckling, där du arbetar nära både teknik, produktion och kund. Du får möjlighet att påverka arbetssätt och struktur, samtidigt som du blir en del av ett bolag med tydlig ambition att utvecklas och bli bättre.

I den här rekryteringen samarbetar Fergas tillsammans med Skill Rekrytering och Bemanning. Om du går vidare kommer du därefter att få ett mejl med en länk till våra arbetspsykologiska tester som på ett objektivt sätt hjälper oss att matcha rätt person till tjänsten. Vid frågor om tjänsten eller rekryteringsprocessen, vänligen kontakta ansvarig rekryterare Anna-Stina Pantzare på anna-stina.panztare@skill.se.

Med anledning av semesterperiod kommer vi att återkoppla på din ansökan efter v.32.

Vi ser fram emot din ansökan!

Fergas Group är en verkstadskoncern med huvudkontor i Linköping, där bolaget grundades för över 75 år sedan. Vi utvecklar, producerar och säljer fläktar och fläktsystem till en lång rad olika applikationer – från ventilation och uppvärmning till vitvaror och fordonsindustrin.

Koncernen har tillverkningsenheter i Sverige, Italien och Kina samt säljkontor i USA, Brasilien och Indien. Vi är cirka 150 medarbetare globalt och arbetar under devisen “Your Global Partner in Air Moving Solutions”.

Hos oss får du arbeta i en verksamhet med korta beslutsvägar, stort eget ansvar och nära samarbete mellan teknik, produktion och affär.

#LI-DNI

Som kvalitetsingenjör på Fergas får du en bred och verksamhetsnära roll med stort fokus på förbättringsarbete, kunddialog och kvalitetssäkring genom hela värdekedjan. En viktig del av uppdraget är att minska gapet mellan produktion, konstruktion och kvalitet, och säkerställa att vi arbetar strukturerat, förebyggande och med rätt fokus.

Du kommer arbeta med avvikelsehantering, kundreklamationer och grundorsaksanalyser - vilket utgör en central del av rollen. Samtidigt är du med och driver förbättringar i produktion och verksamhet, där du både utmanar och stöttar organisationen i kvalitetsfrågor. I rollen ingår även att arbeta med och utveckla ledningssystem enligt ISO-standarder, delta i FMEA-arbete samt bidra till vårt hållbarhetsarbete, exempelvis kopplat till leverantörsdata och kemikaliehantering. På sikt finns också möjlighet att vara med och utveckla arbetssätt kring livscykelanalys.

Rollen rör sig i gränslandet mellan produktion och produktutveckling. Du behöver inte äga alla delar men du behöver förstå helheten, ställa rätt frågor och driva arbetet framåt. Du kommer arbeta nära flera funktioner, inte minst produktionsteknik, konstruktion och inköp.

• Driva och följa upp avvikelsehantering samt genomföra grundorsaksanalyser

• Hantera kundreklamationer och bidra i dialogen med både kunder och leverantörer

• Identifiera och driva förbättringsinitiativ i produktion och verksamhet

• Stötta organisationen i kvalitetsfrågor genom struktur, arbetssätt och utbildning

• Arbeta med och vidareutveckla ledningssystem samt delta i interna revisioner

• Medverka i FMEA-arbete och kvalitetssäkring i både produktion och utveckling

Vi tror att du har några års erfarenhet inom kvalitet i en industriell miljö, och att du är trygg i att driva frågor framåt, även när det kräver tydlighet och struktur.

Du behöver inte kunna allt från start. Det viktiga är att du har rätt grund, rätt inställning och en vilja att utvecklas tillsammans med oss.

Vi ser gärna att du har:

• Civil- eller högskoleingenjörsutbildning

• Erfarenhet av kvalitetsarbete inom industri

• God förståelse för ISO9001 och ISO14001

• Erfarenhet av avvikelsehantering eller grundorsaksanalyser

• Vana att arbeta med kunder eller leverantörer i kvalitetsfrågor

Det är meriterande om du har erfarenhet av exempelvis IATF16949, FMEA, statistiska metoder eller LEAN, samt ett intresse för produktions- eller produktutveckling ur ett kvalitetsperspektiv.

För att lyckas i rollen behöver du kombinera struktur med genomförandekraft. Du är inte rädd för att ställa krav, men gör det på ett sätt som får med dig organisationen. Du är tydlig, kommunikativ och har en förmåga att engagera andra, samtidigt som du är principfast och vågar stå på dig när det behövs.

Du gillar att göra saker bättre – på riktigt.

Här får du en central roll i verksamhetens utveckling, där du arbetar nära både teknik, produktion och kund. Du får möjlighet att påverka arbetssätt och struktur, samtidigt som du blir en del av ett bolag med tydlig ambition att utvecklas och bli bättre.

I den här rekryteringen samarbetar Fergas tillsammans med Skill Rekrytering och Bemanning. Om du går vidare kommer du därefter att få ett mejl med en länk till våra arbetspsykologiska tester som på ett objektivt sätt hjälper oss att matcha rätt person till tjänsten. Vid frågor om tjänsten eller rekryteringsprocessen, vänligen kontakta ansvarig rekryterare Anna-Stina Pantzare på anna-stina.panztare@skill.se.

Med anledning av semesterperiod kommer vi att återkoppla på din ansökan efter v.32.

Vi ser fram emot din ansökan!

Fergas Group är en verkstadskoncern med huvudkontor i Linköping, där bolaget grundades för över 75 år sedan. Vi utvecklar, producerar och säljer fläktar och fläktsystem till en lång rad olika applikationer – från ventilation och uppvärmning till vitvaror och fordonsindustrin.

Koncernen har tillverkningsenheter i Sverige, Italien och Kina samt säljkontor i USA, Brasilien och Indien. Vi är cirka 150 medarbetare globalt och arbetar under devisen “Your Global Partner in Air Moving Solutions”.

Hos oss får du arbeta i en verksamhet med korta beslutsvägar, stort eget ansvar och nära samarbete mellan teknik, produktion och affär.

#LI-DNI

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The Sr Quality Engineer is responsible for acting as Workstream Lead Quality (QE Lead) in the Design & Development projects as responsible for design assurance activities across all project phases ensuring quality and robustness of the product design and manufacturing processes (including product care projects, design changes and design reviews).

Furthermore, the Quality representative is responsible to assure compliance with applicable regulations and SHL Medical AB’s Quality Management System (QMS) in both Design & Development Projects and other Quality element tasks such as CAPAs and Change Control handling.

Main Responsibilities

• Maintain and calibrate laboratory equipment and instruments to ensure operational reliability and compliance.
• To act as Workstream Lead Quality applying Quality Engineering principles in a dynamic way in development and production projects.
• To represent Workstream Lead Quality in all Design Controls and Product Development related aspects.
• To ensure that all design control and production/process control projects meet applicable (local and international) regulations, Corporate, Customer, and Local QMS requirements.
• To utilize Quality Engineering best practices, ensuring internal and external customers’ needs and requirements are built into new products and future product changes.
• To support SMEs in the identification and traceability of Critical to Quality attributes by applying Advanced Product Quality Planning/DFSS/Risk tools and techniques across all product development phases. To promote the use of statistics in testing and control of quality.
• To support and guide Risk Management activities (FMEAs). To assess and approve the risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, product and process controls.
• To support Device product/process development and production activities, including the following:
• Develop or review product/process specifications and requirements.
• Develop or review product reliability specifications/predictions, and reliability test activities.
• To develop quality plans and work further with Manufacturing on the transfer of quality requirements.
• To contribute to compilation and maintenance of Design History Files (DHF).

Minimum requirements

• Minimum 5+ years' work experience in relevant roles such as Quality Assurance, Quality Engineering
• Fluent in written and spoken English.
• Experience from working with interpretation of ISO Standards, e.g EN ISO 14971:2019 and EN ISO 13485:2016
• Experience in establishing, reviewing and approving quality documentation
• Experience with model development, test method validation and statistical analysis.
• Green Belt practitioner, or demonstrated experience in application of Quality Methodologies such as DFSS, DMAIC, Lean
• Hands-on experience in product development from ideation to launch in the Medical Device Industry

Preferred Qualifications

• Fluent in written and spoken Swedish.
• Experience with Design Controls and Design Transfer activities within the Medical Device industry
• Experience with injection molding and automated assembly manufacturing processes.
• Familiarity with validation activities including IQ/OQ/PQ and Test Method Validation (TMV).
• Experience working in cross-functional and international environments.

We Offer

• Challenging assignments in a fast-growing and innovative industry.
• An exciting opportunity in a fast-growing international medical technology company.
• A modern working environment with multicultural and dynamic teams.
• A centrally located office in Zug, very close to the train station.

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.

Please note: We do not accept applications from recruitment agencies for this position

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The Sr Quality Engineer is responsible for acting as Workstream Lead Quality (QE Lead) in the Design & Development projects as responsible for design assurance activities across all project phases ensuring quality and robustness of the product design and manufacturing processes (including product care projects, design changes and design reviews).

Furthermore, the Quality representative is responsible to assure compliance with applicable regulations and SHL Medical AB’s Quality Management System (QMS) in both Design & Development Projects and other Quality element tasks such as CAPAs and Change Control handling.

Main Responsibilities

• Maintain and calibrate laboratory equipment and instruments to ensure operational reliability and compliance.
• To act as Workstream Lead Quality applying Quality Engineering principles in a dynamic way in development and production projects.
• To represent Workstream Lead Quality in all Design Controls and Product Development related aspects.
• To ensure that all design control and production/process control projects meet applicable (local and international) regulations, Corporate, Customer, and Local QMS requirements.
• To utilize Quality Engineering best practices, ensuring internal and external customers’ needs and requirements are built into new products and future product changes.
• To support SMEs in the identification and traceability of Critical to Quality attributes by applying Advanced Product Quality Planning/DFSS/Risk tools and techniques across all product development phases. To promote the use of statistics in testing and control of quality.
• To support and guide Risk Management activities (FMEAs). To assess and approve the risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, product and process controls.
• To support Device product/process development and production activities, including the following:
• Develop or review product/process specifications and requirements.
• Develop or review product reliability specifications/predictions, and reliability test activities.
• To develop quality plans and work further with Manufacturing on the transfer of quality requirements.
• To contribute to compilation and maintenance of Design History Files (DHF).

Minimum requirements

• Minimum 5+ years' work experience in relevant roles such as Quality Assurance, Quality Engineering
• Fluent in written and spoken English.
• Experience from working with interpretation of ISO Standards, e.g EN ISO 14971:2019 and EN ISO 13485:2016
• Experience in establishing, reviewing and approving quality documentation
• Experience with model development, test method validation and statistical analysis.
• Green Belt practitioner, or demonstrated experience in application of Quality Methodologies such as DFSS, DMAIC, Lean
• Hands-on experience in product development from ideation to launch in the Medical Device Industry

Preferred Qualifications

• Fluent in written and spoken Swedish.
• Experience with Design Controls and Design Transfer activities within the Medical Device industry
• Experience with injection molding and automated assembly manufacturing processes.
• Familiarity with validation activities including IQ/OQ/PQ and Test Method Validation (TMV).
• Experience working in cross-functional and international environments.

We Offer

• Challenging assignments in a fast-growing and innovative industry.
• An exciting opportunity in a fast-growing international medical technology company.
• A modern working environment with multicultural and dynamic teams.
• A centrally located office in Zug, very close to the train station.

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.

Please note: We do not accept applications from recruitment agencies for this position

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The Sr Quality Engineer is responsible for acting as Workstream Lead Quality (QE Lead) in the Design & Development projects as responsible for design assurance activities across all project phases ensuring quality and robustness of the product design and manufacturing processes (including product care projects, design changes and design reviews).

Furthermore, the Quality representative is responsible to assure compliance with applicable regulations and SHL Medical AB’s Quality Management System (QMS) in both Design & Development Projects and other Quality element tasks such as CAPAs and Change Control handling.

Main Responsibilities

• Maintain and calibrate laboratory equipment and instruments to ensure operational reliability and compliance.
• To act as Workstream Lead Quality applying Quality Engineering principles in a dynamic way in development and production projects.
• To represent Workstream Lead Quality in all Design Controls and Product Development related aspects.
• To ensure that all design control and production/process control projects meet applicable (local and international) regulations, Corporate, Customer, and Local QMS requirements.
• To utilize Quality Engineering best practices, ensuring internal and external customers’ needs and requirements are built into new products and future product changes.
• To support SMEs in the identification and traceability of Critical to Quality attributes by applying Advanced Product Quality Planning/DFSS/Risk tools and techniques across all product development phases. To promote the use of statistics in testing and control of quality.
• To support and guide Risk Management activities (FMEAs). To assess and approve the risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, product and process controls.
• To support Device product/process development and production activities, including the following:
• Develop or review product/process specifications and requirements.
• Develop or review product reliability specifications/predictions, and reliability test activities.
• To develop quality plans and work further with Manufacturing on the transfer of quality requirements.
• To contribute to compilation and maintenance of Design History Files (DHF).

Minimum requirements

• Minimum 5+ years' work experience in relevant roles such as Quality Assurance, Quality Engineering
• Fluent in written and spoken English.
• Experience from working with interpretation of ISO Standards, e.g EN ISO 14971:2019 and EN ISO 13485:2016
• Experience in establishing, reviewing and approving quality documentation
• Experience with model development, test method validation and statistical analysis.
• Green Belt practitioner, or demonstrated experience in application of Quality Methodologies such as DFSS, DMAIC, Lean
• Hands-on experience in product development from ideation to launch in the Medical Device Industry

Preferred Qualifications

• Fluent in written and spoken Swedish.
• Experience with Design Controls and Design Transfer activities within the Medical Device industry
• Experience with injection molding and automated assembly manufacturing processes.
• Familiarity with validation activities including IQ/OQ/PQ and Test Method Validation (TMV).
• Experience working in cross-functional and international environments.

We Offer

• Challenging assignments in a fast-growing and innovative industry.
• An exciting opportunity in a fast-growing international medical technology company.
• A modern working environment with multicultural and dynamic teams.
• A centrally located office in Zug, very close to the train station.

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.

Please note: We do not accept applications from recruitment agencies for this position

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The Sr Quality Engineer is responsible for acting as Workstream Lead Quality (QE Lead) in the Design & Development projects as responsible for design assurance activities across all project phases ensuring quality and robustness of the product design and manufacturing processes (including product care projects, design changes and design reviews).

Furthermore, the Quality representative is responsible to assure compliance with applicable regulations and SHL Medical AB’s Quality Management System (QMS) in both Design & Development Projects and other Quality element tasks such as CAPAs and Change Control handling.

Main Responsibilities

• Maintain and calibrate laboratory equipment and instruments to ensure operational reliability and compliance.
• To act as Workstream Lead Quality applying Quality Engineering principles in a dynamic way in development and production projects.
• To represent Workstream Lead Quality in all Design Controls and Product Development related aspects.
• To ensure that all design control and production/process control projects meet applicable (local and international) regulations, Corporate, Customer, and Local QMS requirements.
• To utilize Quality Engineering best practices, ensuring internal and external customers’ needs and requirements are built into new products and future product changes.
• To support SMEs in the identification and traceability of Critical to Quality attributes by applying Advanced Product Quality Planning/DFSS/Risk tools and techniques across all product development phases. To promote the use of statistics in testing and control of quality.
• To support and guide Risk Management activities (FMEAs). To assess and approve the risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, product and process controls.
• To support Device product/process development and production activities, including the following:
• Develop or review product/process specifications and requirements.
• Develop or review product reliability specifications/predictions, and reliability test activities.
• To develop quality plans and work further with Manufacturing on the transfer of quality requirements.
• To contribute to compilation and maintenance of Design History Files (DHF).

Minimum requirements

• Minimum 5+ years' work experience in relevant roles such as Quality Assurance, Quality Engineering
• Fluent in written and spoken English.
• Experience from working with interpretation of ISO Standards, e.g EN ISO 14971:2019 and EN ISO 13485:2016
• Experience in establishing, reviewing and approving quality documentation
• Experience with model development, test method validation and statistical analysis.
• Green Belt practitioner, or demonstrated experience in application of Quality Methodologies such as DFSS, DMAIC, Lean
• Hands-on experience in product development from ideation to launch in the Medical Device Industry

Preferred Qualifications

• Fluent in written and spoken Swedish.
• Experience with Design Controls and Design Transfer activities within the Medical Device industry
• Experience with injection molding and automated assembly manufacturing processes.
• Familiarity with validation activities including IQ/OQ/PQ and Test Method Validation (TMV).
• Experience working in cross-functional and international environments.

We Offer

• Challenging assignments in a fast-growing and innovative industry.
• An exciting opportunity in a fast-growing international medical technology company.
• A modern working environment with multicultural and dynamic teams.
• A centrally located office in Zug, very close to the train station.

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.

Please note: We do not accept applications from recruitment agencies for this position

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The Sr Quality Engineer is responsible for acting as Workstream Lead Quality (QE Lead) in the Design & Development projects as responsible for design assurance activities across all project phases ensuring quality and robustness of the product design and manufacturing processes (including product care projects, design changes and design reviews).

Furthermore, the Quality representative is responsible to assure compliance with applicable regulations and SHL Medical AB’s Quality Management System (QMS) in both Design & Development Projects and other Quality element tasks such as CAPAs and Change Control handling.

Main Responsibilities

• Maintain and calibrate laboratory equipment and instruments to ensure operational reliability and compliance.
• To act as Workstream Lead Quality applying Quality Engineering principles in a dynamic way in development and production projects.
• To represent Workstream Lead Quality in all Design Controls and Product Development related aspects.
• To ensure that all design control and production/process control projects meet applicable (local and international) regulations, Corporate, Customer, and Local QMS requirements.
• To utilize Quality Engineering best practices, ensuring internal and external customers’ needs and requirements are built into new products and future product changes.
• To support SMEs in the identification and traceability of Critical to Quality attributes by applying Advanced Product Quality Planning/DFSS/Risk tools and techniques across all product development phases. To promote the use of statistics in testing and control of quality.
• To support and guide Risk Management activities (FMEAs). To assess and approve the risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, product and process controls.
• To support Device product/process development and production activities, including the following:
• Develop or review product/process specifications and requirements.
• Develop or review product reliability specifications/predictions, and reliability test activities.
• To develop quality plans and work further with Manufacturing on the transfer of quality requirements.
• To contribute to compilation and maintenance of Design History Files (DHF).

Minimum requirements

• Minimum 5+ years' work experience in relevant roles such as Quality Assurance, Quality Engineering
• Fluent in written and spoken English.
• Experience from working with interpretation of ISO Standards, e.g EN ISO 14971:2019 and EN ISO 13485:2016
• Experience in establishing, reviewing and approving quality documentation
• Experience with model development, test method validation and statistical analysis.
• Green Belt practitioner, or demonstrated experience in application of Quality Methodologies such as DFSS, DMAIC, Lean
• Hands-on experience in product development from ideation to launch in the Medical Device Industry

Preferred Qualifications

• Fluent in written and spoken Swedish.
• Experience with Design Controls and Design Transfer activities within the Medical Device industry
• Experience with injection molding and automated assembly manufacturing processes.
• Familiarity with validation activities including IQ/OQ/PQ and Test Method Validation (TMV).
• Experience working in cross-functional and international environments.

We Offer

• Challenging assignments in a fast-growing and innovative industry.
• An exciting opportunity in a fast-growing international medical technology company.
• A modern working environment with multicultural and dynamic teams.
• A centrally located office in Zug, very close to the train station.

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.

Please note: We do not accept applications from recruitment agencies for this position

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The Sr Quality Engineer is responsible for acting as Workstream Lead Quality (QE Lead) in the Design & Development projects as responsible for design assurance activities across all project phases ensuring quality and robustness of the product design and manufacturing processes (including product care projects, design changes and design reviews).

Furthermore, the Quality representative is responsible to assure compliance with applicable regulations and SHL Medical AB’s Quality Management System (QMS) in both Design & Development Projects and other Quality element tasks such as CAPAs and Change Control handling.

Main Responsibilities

• Maintain and calibrate laboratory equipment and instruments to ensure operational reliability and compliance.
• To act as Workstream Lead Quality applying Quality Engineering principles in a dynamic way in development and production projects.
• To represent Workstream Lead Quality in all Design Controls and Product Development related aspects.
• To ensure that all design control and production/process control projects meet applicable (local and international) regulations, Corporate, Customer, and Local QMS requirements.
• To utilize Quality Engineering best practices, ensuring internal and external customers’ needs and requirements are built into new products and future product changes.
• To support SMEs in the identification and traceability of Critical to Quality attributes by applying Advanced Product Quality Planning/DFSS/Risk tools and techniques across all product development phases. To promote the use of statistics in testing and control of quality.
• To support and guide Risk Management activities (FMEAs). To assess and approve the risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, product and process controls.
• To support Device product/process development and production activities, including the following:
• Develop or review product/process specifications and requirements.
• Develop or review product reliability specifications/predictions, and reliability test activities.
• To develop quality plans and work further with Manufacturing on the transfer of quality requirements.
• To contribute to compilation and maintenance of Design History Files (DHF).

Minimum requirements

• Minimum 5+ years' work experience in relevant roles such as Quality Assurance, Quality Engineering
• Fluent in written and spoken English.
• Experience from working with interpretation of ISO Standards, e.g EN ISO 14971:2019 and EN ISO 13485:2016
• Experience in establishing, reviewing and approving quality documentation
• Experience with model development, test method validation and statistical analysis.
• Green Belt practitioner, or demonstrated experience in application of Quality Methodologies such as DFSS, DMAIC, Lean
• Hands-on experience in product development from ideation to launch in the Medical Device Industry

Preferred Qualifications

• Fluent in written and spoken Swedish.
• Experience with Design Controls and Design Transfer activities within the Medical Device industry
• Experience with injection molding and automated assembly manufacturing processes.
• Familiarity with validation activities including IQ/OQ/PQ and Test Method Validation (TMV).
• Experience working in cross-functional and international environments.

We Offer

• Challenging assignments in a fast-growing and innovative industry.
• An exciting opportunity in a fast-growing international medical technology company.
• A modern working environment with multicultural and dynamic teams.
• A centrally located office in Zug, very close to the train station.

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.

Please note: We do not accept applications from recruitment agencies for this position

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The Sr Quality Engineer is responsible for acting as Workstream Lead Quality (QE Lead) in the Design & Development projects as responsible for design assurance activities across all project phases ensuring quality and robustness of the product design and manufacturing processes (including product care projects, design changes and design reviews).

Furthermore, the Quality representative is responsible to assure compliance with applicable regulations and SHL Medical AB’s Quality Management System (QMS) in both Design & Development Projects and other Quality element tasks such as CAPAs and Change Control handling.

Main Responsibilities

• Maintain and calibrate laboratory equipment and instruments to ensure operational reliability and compliance.
• To act as Workstream Lead Quality applying Quality Engineering principles in a dynamic way in development and production projects.
• To represent Workstream Lead Quality in all Design Controls and Product Development related aspects.
• To ensure that all design control and production/process control projects meet applicable (local and international) regulations, Corporate, Customer, and Local QMS requirements.
• To utilize Quality Engineering best practices, ensuring internal and external customers’ needs and requirements are built into new products and future product changes.
• To support SMEs in the identification and traceability of Critical to Quality attributes by applying Advanced Product Quality Planning/DFSS/Risk tools and techniques across all product development phases. To promote the use of statistics in testing and control of quality.
• To support and guide Risk Management activities (FMEAs). To assess and approve the risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, product and process controls.
• To support Device product/process development and production activities, including the following:
• Develop or review product/process specifications and requirements.
• Develop or review product reliability specifications/predictions, and reliability test activities.
• To develop quality plans and work further with Manufacturing on the transfer of quality requirements.
• To contribute to compilation and maintenance of Design History Files (DHF).

Minimum requirements

• Minimum 5+ years' work experience in relevant roles such as Quality Assurance, Quality Engineering
• Fluent in written and spoken English.
• Experience from working with interpretation of ISO Standards, e.g EN ISO 14971:2019 and EN ISO 13485:2016
• Experience in establishing, reviewing and approving quality documentation
• Experience with model development, test method validation and statistical analysis.
• Green Belt practitioner, or demonstrated experience in application of Quality Methodologies such as DFSS, DMAIC, Lean
• Hands-on experience in product development from ideation to launch in the Medical Device Industry

Preferred Qualifications

• Fluent in written and spoken Swedish.
• Experience with Design Controls and Design Transfer activities within the Medical Device industry
• Experience with injection molding and automated assembly manufacturing processes.
• Familiarity with validation activities including IQ/OQ/PQ and Test Method Validation (TMV).
• Experience working in cross-functional and international environments.

We Offer

• Challenging assignments in a fast-growing and innovative industry.
• An exciting opportunity in a fast-growing international medical technology company.
• A modern working environment with multicultural and dynamic teams.
• A centrally located office in Zug, very close to the train station.

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.

Please note: We do not accept applications from recruitment agencies for this position