<p><b>Thoratec Switzerland GmbH</b>, part of <b>Abbott Laboratories</b>, 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.</p><p></p><p>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 <b>Manager Quality System & Regulatory Compliance </b>who is motivated by purpose, collaboration, and continuous improvement.</p><p></p><p><b>The Role</b></p><p></p><p>In 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.</p><p>This position offers the opportunity to <b>combine people leadership, strategic influence, and hands-on quality expertise</b> in a global, regulated medical device environment.</p><p></p><p><b>What You’ll Do</b></p><p></p><p><b>Lead & Inspire</b></p><ul><li><p>Lead, support, and develop a team of Quality System specialists, setting clear goals aligned with company objectives and regulatory requirements</p></li><li><p>Foster a collaborative, inclusive, and accountable team environment</p></li><li><p>Support performance development through coaching, feedback, and training</p></li></ul><p></p><p><b>Quality & Compliance Leadership</b></p><ul><li><p>Ensure effective execution and continuous improvement of the site’s Quality Management Systems</p></li><li><p>Maintain compliance with applicable international standards and regulations (e.g. ISO 13485, FDA QSR, EU MDR)</p></li><li><p>Prepare and support the site during external audits and regulatory inspections (e.g. FDA, Notified Bodies)</p></li><li><p>Act as a key quality partner for Operations, R&D, Engineering, and Regulatory Affairs</p></li></ul><p></p><p><b>Continuous Improvement & Problem Solving</b></p><ul><li><p>Identify opportunities to improve processes, compliance, and efficiency across the organization</p></li><li><p>Lead or contribute to global quality improvement initiatives</p></li><li><p>Own and drive corrective and preventive actions (CAPA), including root cause analysis and sustainable solutions</p></li></ul><p></p><p><b>Collaboration & Communication</b></p><ul><li><p>Operate effectively in a matrixed, international environment</p></li><li><p>Build trusted relationships with global and regional stakeholders</p></li><li><p>Communicate clearly and confidently across technical and non‑technical audiences</p></li></ul><p></p><p><b>Your Expertise</b></p><p></p><p><b>Required</b></p><ul><li><p>Master’s degree in science, engineering, or another relevant technical discipline</p></li><li><p>3–5 years of experience in quality systems within the medical device industry (or similarly regulated environment)</p></li><li><p>Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDD/MDR, MDSAP</p></li><li><p>Experience leading teams or guiding others in a regulated setting</p></li><li><p>Strong communication skills in English and German</p></li></ul><p></p><p><b>What Helps You Succeed</b></p><ul><li><p>You balance attention to detail with a pragmatic, solution‑oriented mindset</p></li><li><p>You enjoy developing people and helping teams perform at their best</p></li><li><p>You are comfortable influencing in a matrix organization</p></li><li><p>You value high ethical standards and taking ownership</p></li></ul><p><i>I</i></p><p><i>f you don’t meet every requirement but believe this role is a strong fit for your experience and aspirations, we encourage you to apply.</i></p><p></p><p><b>What We Offer</b></p><ul><li><p>Meaningful work that directly impacts patient lives</p></li><li><p>A stable and growing company in a resilient industry</p></li><li><p>A collaborative, respectful, and international working environment</p></li><li><p>Flat hierarchies with open and transparent communication</p></li><li><p>Opportunities for personal and professional development within Abbott</p></li><li><p>A modern workplace in the center of Zurich, with R&D and manufacturing on site</p></li></ul><p></p><p><b>Ready to Apply?</b></p><p>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.</p><p></p><p></p>
