Senior Quality Assurance R&D Professional

10 hours ago


Ballerup, Ballerup Kommune, Denmark Ambu AS Full time

Overview

Ambu A/S, a global company with a strong focus on quality, is seeking a skilled Senior Quality Assurance R&D Specialist to join its Global Quality Management R&D department.

The ideal candidate will have a strong background in quality management support for medical device development, particularly in medical electrical equipment.

This position can be based out of either Ballerup or Augsburg and offers a dynamic working environment where the individual will have opportunities to influence Ambu's processes and daily tasks.

Main Responsibilities:

  1. Drive global R&D project activities as QM lead
  2. Take ownership of and lead Risk Management activities within R&D projects
  3. Act as contact person for requirements related to basic safety and essential performance
  4. Handle and monitor CAPA; Non-conformities; Planned Deviations
  5. Participate in Notified Body audits and inspections by authorities

Required Skills and Qualifications:

  • Rlevant academic background (BSc/MSc)
  • At least 5 years' experience in quality organization for Medical Devices
  • Demonstrated experience in IEC 60601
  • In-depth knowledge of ISO 14971
  • In-depth knowledge of relevant regulations for medical devices (ISO13485, EU MDR, MDSAP, UK MD)
  • Ideal: knowledge in IEC 62304

About the Role:

This is an exciting opportunity for a motivated and experienced professional to take on a key role in our Global Quality Management R&D department.

We offer a competitive salary and benefits package, including:

  • Estimated salary: €60,000 - €80,000 per year
  • Pension scheme
  • Health insurance
  • Generous holiday entitlement

What We Offer:

Ambu A/S is a visionary and international workplace where your efforts matter. We meet our ambitious growth targets through interdisciplinary teamwork between motivated and highly skilled employees.

Your contributions and efforts are crucial to our success, and by joining us, you will get the opportunity to work in an international head office with an informal working environment.



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