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.
We are seeking a detail-oriented and experienced Senior CAPA Specialist to join our team.
Position Overview:
The Senior CAPA Specialist will be responsible for managing the Corrective and Preventive Action (CAPA) process to ensure compliance with regulatory requirements and internal quality standards. This role involves investigating non-conformances, identifying root causes, and implementing effective corrective and preventive actions.
Key Responsibilities:
Manage the CAPA process of multiple CAPAs from initiation to closure, ensuring timely and effective resolution of issues with minimal oversight and direct others.
Conduct thorough investigations of complex non-conformances and deviations to identify root causes and develop strategy with appropriate business acumen.
Develop and implement corrective and preventive action plans to address identified issues.
Monitor the effectiveness of CAPA actions and make necessary adjustments.
Collaborate with cross-functional teams and multiple sites to ensure CAPA actions are integrated into relevant processes.
Maintain excellent accurate and detailed documentation of CAPA activities.
Prepare and present CAPA reports to management and regulatory bodies as required.
Stay updated on industry regulations and best practices related to CAPA.
Qualifications:
Master's degree in a related field (e.g., Quality Assurance, Engineering, Life Sciences).
Minimum of 9 years of experience in CAPA management or a related quality assurance role.
Strong understanding of regulatory requirements (e.g., FDA, ISO) and quality management systems.
Excellent problem-solving and analytical skills.
Strong communication and interpersonal skills.
Ability to work independently and as part of a team.
Proficiency in using quality management software and tools.
Fluency in English is required and German is a plus.
Preferred Qualifications:
Certification in Quality Management (e.g., ASQ CQE, CQA).
Experience in [specific industry, e.g., medical devices, pharmaceuticals].
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
We are looking for highly motivated person who would like to be part of our passionate team with broad responsibilities. Do you have what it takes? Then send us your application including motivation letter, curriculum vitae, letter of recommendation and diplomas today. We are looking forward to meeting you in the heart of Zurich!
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