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Medical Device Industry
 


Our client is a wholly owned subsidiary of Thoratec Corporation (www.thoratec.com). For more than 30 years, Thoratec has been committed to developing advanced medical technologies to improve patient survival and quality of life. Thoratec provides the broadest mechanical circulatory support portfolio to treat the full range of clinical needs. From acute to chronic heart failure, Thoratec offers proven device-based therapies to provide a new beginning for patients and their families.

At its R&D and Manufacturing site based in Zurich (approx. 25 employees) there is a challenging opening for a committed, goal-oriented professional as

Manager, Quality Assurance
 


responsible for the maintenance and expansion of the quality assurance procedures according to FDA/GMP, ISO 13485 and the Company Corporate Quality Manual; being supported by a QC-Engineer and reporting to Director QA Global at US Headquarters.

In this function you oversee all aspects of the production quality assurance and document control activities to ensure compliance with internal procedures and regulatory standards. You manage the tasks of the Quality organization with responsibility for results in terms of product quality, performance and safety. Furthermore you provide support and communication with Operations and customers to resolve quality issues and other related product concerns, and you actively drive all defined Quality Systems goals and objectives at the site level.

Your profile: Bachelors degree in Science, Engineering or other technical field with additional education in QM as well as a minimum of 5 years comparable experience in a medical device manufacturing environment or other FDA/ISO regulated industry in a quality related role with international exposure. You are a person with initiative and excellent organizational, multi tasking and communication skills and the ability to transfer know-how and to motivate people involved. Fluency in German and English are further requirements.

If you are attracted by this exciting opportunity within a small company but leading player in its market niche, please send your complete documentation (covering letter and CV in English) to the attention of Mr. T. Lüchinger.