JOB DESCRIPTION:
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
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:HF Heart Failure
LOCATION:Switzerland : Technoparkstrass 1 CH 8005
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Not Applicable
Top Skills
What We Do
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
