Manager Quality System & Regulatory Compliance

03 April 2026
100%
Permanent position
Zurich

Job summary

Join Thoratec Switzerland GmbH, an Abbott Laboratories company, leading in blood pump systems. Be part of our innovative team in Zurich!

Tasks

Lead and develop a team of Quality System specialists.
Ensure compliance with international quality standards and regulations.
Drive continuous improvement initiatives across the organization.

Skills

Master's degree and 3-5 years in medical device quality systems required.
Strong knowledge of ISO 13485 and FDA regulations.
Excellent communication skills in English and German.

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About the job

Thoratec Switzerland GmbH, part of Abbott Laboratories, is a global leader in implantable and extracorporeal blood pump systems. Our lifesaving medical devices, developed and manufactured at our Zurich site, support patients with severe heart disease worldwide.Our Zurich team of approximately 150 colleagues brings together expertise across R&D, manufacturing, quality, and regulatory functions. As we continue to expand our innovative and high-impact work, we are looking for an experienced Manager Quality System & Regulatory Compliance who is motivated by purpose, collaboration, and continuous improvement.The RoleIn this role, you will shape and strengthen our Quality Management Systems while leading and developing a team of Quality System specialists. You will work closely with colleagues across Operations, R&D, Engineering, and Regulatory Affairs to ensure our products and processes meet the highest regulatory and quality standards — always with patient safety at the center.This position offers the opportunity to combine people leadership, strategic influence, and hands-on quality expertise in a global, regulated medical device environment.What You’ll DoLead & Inspire<ul><li>Lead, support, and develop a team of Quality System specialists, setting clear goals aligned with company objectives and regulatory requirements</li><li>Foster a collaborative, inclusive, and accountable team environment</li><li>Support performance development through coaching, feedback, and training</li></ul>Quality & Compliance Leadership<ul><li>Ensure effective execution and continuous improvement of the site’s Quality Management Systems</li><li>Maintain compliance with applicable international standards and regulations (e.g. ISO 13485, FDA QSR, EU MDR)</li><li>Prepare and support the site during external audits and regulatory inspections (e.g. FDA, Notified Bodies)</li><li>Act as a key quality partner for Operations, R&D, Engineering, and Regulatory Affairs</li></ul>Continuous Improvement & Problem Solving<ul><li>Identify opportunities to improve processes, compliance, and efficiency across the organization</li><li>Lead or contribute to global quality improvement initiatives</li><li>Own and drive corrective and preventive actions (CAPA), including root cause analysis and sustainable solutions</li></ul>Collaboration & Communication<ul><li>Operate effectively in a matrixed, international environment</li><li>Build trusted relationships with global and regional stakeholders</li><li>Communicate clearly and confidently across technical and non‑technical audiences</li></ul>Your ExpertiseRequired<ul><li>Master’s degree in science, engineering, or another relevant technical discipline</li><li>3–5 years of experience in quality systems within the medical device industry (or similarly regulated environment)</li><li>Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDD/MDR, MDSAP</li><li>Experience leading teams or guiding others in a regulated setting</li><li>Strong communication skills in English and German</li></ul>What Helps You Succeed<ul><li>You balance attention to detail with a pragmatic, solution‑oriented mindset</li><li>You enjoy developing people and helping teams perform at their best</li><li>You are comfortable influencing in a matrix organization</li><li>You value high ethical standards and taking ownership</li></ul>If you don’t meet every requirement but believe this role is a strong fit for your experience and aspirations, we encourage you to apply.What We Offer<ul><li>Meaningful work that directly impacts patient lives</li><li>A stable and growing company in a resilient industry</li><li>A collaborative, respectful, and international working environment</li><li>Flat hierarchies with open and transparent communication</li><li>Opportunities for personal and professional development within Abbott</li><li>A modern workplace in the center of Zurich, with R&D and manufacturing on site</li></ul>Ready to Apply?We look forward to receiving your application (CV and motivation letter in PDF format). All qualified applicants are encouraged to apply — we value diversity and believe it strengthens our teams and our impact.