Thoratec Switzerland GmbH
Manager Quality System & Regulatory Compliance(m/w/x)
Full-timeOn-siteExperienced
Zürich
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THThoratec Switzerland GmbH (Abbott)
Supervisor Quality Release(m/w/x)
Zürich
Full-timeOn-siteExperienced
Nejo AI Summary
Overseeing product releases for life-saving heart pump systems. 4-6 years in regulated environments, with people leadership experience required. Development in a crisis-resilient industry, collaborative international team.
Requirements
- Bachelor’s degree or equivalent in relevant discipline
- 4–6 years experience in Quality, QC, or regulated environment
- People leadership experience (ideally 2+ years) or readiness for team-lead role
- Knowledge of ISO 13485, global medical device regulations (21 CFR Part 820, EU MDD/MDR); MDSAP is a plus
- Experience with Class II or Class III medical devices is an advantage
- Strong communication and presentation skills
- Fluent English; German at B1 or higher
- Potential, learning mindset, and motivation
Tasks
- Lead and support the Quality Release team
- Ensure safe, compliant, and efficient product releases
- Foster a collaborative, respectful, and inclusive team culture
- Set clear, achievable goals aligned with site and company objectives
- Provide guidance, feedback, and career development support
- Allocate tasks and resources thoughtfully
- Oversee product release and acceptance activities
- Review production and quality records with stakeholders
- Promote continuous improvement in GDP/GMP compliance
- Act as final decision authority for product release
- Lead or sponsor quality improvement initiatives
- Manage site-specific quality projects
- Create realistic project plans and align milestones
- Support audits and inspections
- Take accountability for quality release decisions
- Partner with Operations, Engineering, and Supply Chain
- Resolve quality issues without disrupting production
- Represent the Quality Release team in Tier meetings
- Train and coach Quality Release operators
Work Experience
- 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Fluent
- German – Advanced
Tools & Technologies
- ISO 13485
- 21 CFR Part 820
- EU MDD/MDR
- MDSAP
Benefits
Purpose-Driven Work
- Life-saving technology development
Career Advancement
- Long-term career development
Job Security
- Stable, crisis-resilient industry
Informal Culture
- Collaborative, international, and highly skilled team
- Inclusive culture
Modern Office
- Modern workplace in Zurich
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thoratec Switzerland GmbH (Abbott) 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 (Abbott)
Supervisor Quality Release(m/w/x)
Zürich
Full-timeOn-siteExperienced
Nejo AI Summary
Overseeing product releases for life-saving heart pump systems. 4-6 years in regulated environments, with people leadership experience required. Development in a crisis-resilient industry, collaborative international team.
Requirements
- Bachelor’s degree or equivalent in relevant discipline
- 4–6 years experience in Quality, QC, or regulated environment
- People leadership experience (ideally 2+ years) or readiness for team-lead role
- Knowledge of ISO 13485, global medical device regulations (21 CFR Part 820, EU MDD/MDR); MDSAP is a plus
- Experience with Class II or Class III medical devices is an advantage
- Strong communication and presentation skills
- Fluent English; German at B1 or higher
- Potential, learning mindset, and motivation
Tasks
- Lead and support the Quality Release team
- Ensure safe, compliant, and efficient product releases
- Foster a collaborative, respectful, and inclusive team culture
- Set clear, achievable goals aligned with site and company objectives
- Provide guidance, feedback, and career development support
- Allocate tasks and resources thoughtfully
- Oversee product release and acceptance activities
- Review production and quality records with stakeholders
- Promote continuous improvement in GDP/GMP compliance
- Act as final decision authority for product release
- Lead or sponsor quality improvement initiatives
- Manage site-specific quality projects
- Create realistic project plans and align milestones
- Support audits and inspections
- Take accountability for quality release decisions
- Partner with Operations, Engineering, and Supply Chain
- Resolve quality issues without disrupting production
- Represent the Quality Release team in Tier meetings
- Train and coach Quality Release operators
Work Experience
- 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Fluent
- German – Advanced
Tools & Technologies
- ISO 13485
- 21 CFR Part 820
- EU MDD/MDR
- MDSAP
Benefits
Purpose-Driven Work
- Life-saving technology development
Career Advancement
- Long-term career development
Job Security
- Stable, crisis-resilient industry
Informal Culture
- Collaborative, international, and highly skilled team
- Inclusive culture
Modern Office
- Modern workplace in Zurich
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thoratec Switzerland GmbH (Abbott) 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Thoratec Switzerland GmbH (Abbott)
Industry
Healthcare
Description
Thoratec Switzerland GmbH, part of Abbott’s medical device division, designs and manufactures life-saving heart pump systems for patients with advanced heart failure.
Not a perfect match?
- Thoratec Switzerland GmbH
Manager Quality System & Regulatory Compliance(m/w/x)
Full-timeOn-siteExperiencedZürich - Thoratec Switzerland GmbH
Manager NPI Engineering(m/w/x)
Full-timeOn-siteSeniorZürich - ThoratecSwitzerland GmbH
Change Control Specialist(m/w/x)
Full-timeOn-siteExperiencedZürich - Creoptix AG
Manager Operations/Plant Manager(m/w/x)
Full-timeOn-siteSeniorWädenswil - SIEGFRIED DiNAMIQS AG
QA Specialist(m/w/x)
Full-timeOn-siteSeniorSchlieren