**Thoratec Switzerland GmbH** is part of the medical device division of **Abbott Laboratories** , a fortune 500 company with over 115’000 employees worldwide. We are the global market leader for implantable and extracorporeal blood pumps based on magnetic levitation technology. Our life-saving systems, which we develop and manufacture in Zurich, are used for advanced heart failure patients needing short- or long-term circulatory support. Our location in the heart of the city of Zurich has around 130 employees in the areas of development, quality and production of the **CentriMag** system and the **HeartMate 3.** **Make a Meaningful Impact — Join Us as a Senior Quality Assurance Specialist** **(CAPA)** Are you passionate about quality, collaboration, and making a difference in healthcare? We’re looking for a **Senior Quality Assurance Specialist** **(CAPA)** to join our team and help us ensure the highest standards in patient safety and product excellence. **Why This Role Matters** In this role, you’ll be at the heart of our quality operations—leading CAPA processes, partnering with cross-functional teams, and contributing to a culture of continuous improvement. You’ll work closely with R&D, Engineering, Operations, and Regulatory Affairs to resolve quality challenges and shape our compliance strategy. What You’ll Do **Lead CAPA Excellence** + Guide and mentor colleagues through CAPA methodology and execution. + Manage CAPA lifecycle from initiation to closure, ensuring timely and effective outcomes. + Review and approve CAPAs, supporting thorough investigations and root cause analysis. + Oversee implementation and verification of corrective and preventive actions. **Strengthen Our Quality System** + Support the development and maintenance of quality procedures aligned with global standards. + Monitor compliance across departments and promote best practices. + Function as contact point for compliance topics to empower teams with quality knowledge. **Support Microbiology & Sterilization** + Collaborate with subject matter experts on microbiological controls and EtO sterilization. + Contribute to environmental monitoring, sterility assurance, and validation activities. + Help ensure compliance with ISO 11135 and related regulatory frameworks. **What You Bring** + A Bachelor’s or Master’s degree in Science, Engineering, or a related technical field. + At least 5 years of experience in the medical device industry, ideally in a quality-focused role. + Strong skills in non-conformance handling, root cause analysis, and CAPA implementation. + Solid understanding of international medical device regulations: + ISO 13485:2016 + 21 CFR Part 820 + EU MDD/MDR + ISO 14971 (Risk Management) + Familiarity with ISO 11135:2018 and/or IEC 60601-1 is a plus. + Excellent communication skills in English. + Strong organizational and time management abilities. + A proactive, ethical mindset and the ability to work both independently and collaboratively. + Confidence using technical software and digital tools. **Working at Abbott** At Abbott, you can do work that matters and help people to live a healthier and fuller life, grow your career, and learn, be your true self. You will have access to: + Career development with an international company where you can grow + A workplace in a fortune 500 company and the world’s leading manufacturer of medical devices + A challenging position in a crisis independent industry + To become part of a dynamic, highly educated, highly skilled, and motivated team + Multi-national environment, where we foster the development of our talents within the enterprise + Competitive compensations and benefits + A workplace in the heart of Zurich Please follow our Career site and check for available openings: Abbott Jobs | Apply Now | Abbott Laboratories Careers (https://www.jobs.abbott/us/en) An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com