Senior Medical Device Quality Assurance Manager

13 hours ago


Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

Ascendis Pharma is a rapidly growing biopharmaceutical company with operations in multiple locations across the globe. Our mission is to develop innovative therapies that make a meaningful difference in patients' lives.

We are seeking an experienced Senior Medical Device Quality Assurance Manager to join our team. This role will be responsible for ensuring the effectiveness of our Quality Management System (QMS) and providing guidance and support to other functions to ensure compliance with regulatory requirements.

The ideal candidate will have a strong background in medical device quality assurance, experience with ISO 13485 and MDSAP, and excellent communication and leadership skills. You will be part of a global team working together to achieve extraordinary results.

In this role, you will:

  • Develop and implement QMS improvement activities
  • Provide guidance on risk-based approaches and justification
  • Support medical device development projects, design transfer, and technical documentation maintenance
  • Release medical devices and components
  • Handle deviations, CAPAs, and change control cases
  • Assist in supplier approval processes
  • Participate in inspections and audits
  • Stay updated on relevant regulatory requirements

This position offers a competitive salary range of $120,000 - $180,000 per year, depending on experience, as well as opportunities for professional growth and development in a dynamic and innovative work environment.



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