QMS Manager

Vor 6 Tagen

Satigny, Schweiz Terapet SA Vollzeit

Terapet SA, a Geneva based CERN MedTech start-up, is developing medical devices based on an innovative technology for imaging in nuclear medicine to take proton therapy to the next level.

We are looking for a motivated and detail-oriented QMS Manager to join our small, dynamic, and passionate team, for a 50% part-time position.

Role: QMS ManagerResponsibilities:

We are seeking a Quality Systems Manager to maintain the Quality Systems function for a fast-growing medical device business, as well as to maintain the risk management for the products currently being developed. As the Quality Systems Manager, you will be responsible for:

  1. Maintenance of the Quality Management System,
  2. Risk Management of devices currently being developed,
  3. Managing the CAPA process, the Complaints process and the Document Control process,
  4. Support the Project Manager with quality aspects during Design and Development activities,
  5. Support the implementation and maintenance of policies and procedures related to manufacturing and sales activities,
  6. Support future extensions of the scope of the QMS, to include compliance with FDA CFR Part 820 and / or MDSAP,
  7. Participate in regulatory inspections and support resolution of any quality-related issues,
  8. Collaborate with other team members and stakeholders,
  9. Coordinate with external collaborators.
Requirements:
  1. Bachelor’s or master’s degree in engineering, life sciences, regulatory affairs or a related field.
  2. Work experience in a regulated field or industry.
  3. Excellent communication and problem-solving skills. Strong attention to detail and ability to prioritize tasks in a fast-paced environment.
  4. Excellent analytical and multitasking skills.
  5. Good knowledge of English.
  6. Willingness to work in Geneva.
Preferred experience:
  1. Experience in Quality Systems management for Medical Devices, including knowledge of ISO 9001, ISO 13485, FDA 21 CFR Part 820, and MDSAP.
  2. Experience in risk management in compliance with ISO 14971.

If you want to know more about this job, please contact us on +41 76 339 9580.

This position will be filled as soon as a suitable candidate is found. If you are interested in this job offer, please send your application (including cover letter and CV) to: recruitment@terapet.ch.

For more information, visit our website or this link.

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