Thoratec Switzerland GmbH
Manager NPI Engineering(m/w/x)
Full-timeOn-siteSenior
Zürich
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THThoratec Switzerland GmbH
Manager Quality System & Regulatory Compliance(m/w/x)
Zürich
Full-timeOn-siteExperienced
Nejo AI Summary
Overseeing ISO 13485 and FDA 21 CFR Part 820 compliance for blood pump systems. 3-5 years of medical device quality systems leadership experience required. Collaborative, international work environment with flat hierarchies.
Requirements
- Master’s degree in science, engineering, or technical discipline
- 3–5 years experience in quality systems (medical device or regulated environment)
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDD/MDR, MDSAP
- Experience leading teams in regulated setting
- Strong English and German communication skills
- Attention to detail and pragmatic mindset
- Enjoy developing people and team performance
- Comfortable influencing in a matrix organization
- High ethical standards and ownership
- Encouraged to apply if not meeting every requirement
Tasks
- Lead and develop Quality System specialists
- Set clear goals aligned with company and regulatory objectives
- Foster a collaborative and inclusive team environment
- Support team performance through coaching and feedback
- Ensure effective execution of Quality Management Systems
- Maintain compliance with international standards (ISO 13485, FDA QSR, EU MDR)
- Prepare for and support external audits and inspections
- Partner with Operations, R&D, Engineering, and Regulatory Affairs
- Identify and implement process improvement opportunities
- Lead or contribute to global quality initiatives
- Drive corrective and preventive actions (CAPA)
- Conduct root cause analysis and develop sustainable solutions
- Operate in a matrixed, international environment
- Build trusted relationships with stakeholders
- Communicate clearly to technical and non-technical audiences
Work Experience
- 3 - 5 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- ISO 13485
- FDA 21 CFR Part 820
- EU MDD/MDR
- MDSAP
Benefits
Purpose-Driven Work
- Meaningful work
Job Security
- Stable and growing company
- Resilient industry
Informal Culture
- Collaborative, respectful, and international working environment
- Flat hierarchies
- Open and transparent communication
Learning & Development
- Personal and professional development opportunities
Modern Office
- Modern workplace in Zurich center
Other Benefits
- On-site R&D and manufacturing
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thoratec Switzerland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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THThoratec Switzerland GmbH
Manager Quality System & Regulatory Compliance(m/w/x)
Zürich
Full-timeOn-siteExperienced
Nejo AI Summary
Overseeing ISO 13485 and FDA 21 CFR Part 820 compliance for blood pump systems. 3-5 years of medical device quality systems leadership experience required. Collaborative, international work environment with flat hierarchies.
Requirements
- Master’s degree in science, engineering, or technical discipline
- 3–5 years experience in quality systems (medical device or regulated environment)
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDD/MDR, MDSAP
- Experience leading teams in regulated setting
- Strong English and German communication skills
- Attention to detail and pragmatic mindset
- Enjoy developing people and team performance
- Comfortable influencing in a matrix organization
- High ethical standards and ownership
- Encouraged to apply if not meeting every requirement
Tasks
- Lead and develop Quality System specialists
- Set clear goals aligned with company and regulatory objectives
- Foster a collaborative and inclusive team environment
- Support team performance through coaching and feedback
- Ensure effective execution of Quality Management Systems
- Maintain compliance with international standards (ISO 13485, FDA QSR, EU MDR)
- Prepare for and support external audits and inspections
- Partner with Operations, R&D, Engineering, and Regulatory Affairs
- Identify and implement process improvement opportunities
- Lead or contribute to global quality initiatives
- Drive corrective and preventive actions (CAPA)
- Conduct root cause analysis and develop sustainable solutions
- Operate in a matrixed, international environment
- Build trusted relationships with stakeholders
- Communicate clearly to technical and non-technical audiences
Work Experience
- 3 - 5 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- ISO 13485
- FDA 21 CFR Part 820
- EU MDD/MDR
- MDSAP
Benefits
Purpose-Driven Work
- Meaningful work
Job Security
- Stable and growing company
- Resilient industry
Informal Culture
- Collaborative, respectful, and international working environment
- Flat hierarchies
- Open and transparent communication
Learning & Development
- Personal and professional development opportunities
Modern Office
- Modern workplace in Zurich center
Other Benefits
- On-site R&D and manufacturing
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thoratec Switzerland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Thoratec Switzerland GmbH
Industry
Healthcare
Description
The company is a global leader in life-saving medical technologies, supporting patients with advanced heart failure.
Not a perfect match?
- Thoratec Switzerland GmbH
Manager NPI Engineering(m/w/x)
Full-timeOn-siteSeniorZürich - ThoratecSwitzerland GmbH
Change Control Specialist(m/w/x)
Full-timeOn-siteExperiencedZürich - NL3M Philips International BV
Patient Safety and Quality Leader DACH(m/w/x)
Full-timeOn-siteManagementHorgen - The Kusnacht Practice AG
Clinical Quality, Process & Medical Procurement Specialist(m/w/x)
Full-timeOn-siteSeniorZollikon - HITACHI ENERGY LTD
Quality Specialist(m/w/x)
Full-timeOn-siteExperiencedWettingen