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Senior QM R&D Expert
1 month ago
Ambu A/S is seeking a Senior QM R&D Expert to drive global cutting-edge projects and ensure compliance with international regulations.
About the RoleThis dynamic position offers a unique opportunity to join our Global Quality Management R&D department and contribute to the development of innovative medical device solutions. As a key player in our team, you will be responsible for leading Risk Management activities, handling CAPA, Non-conformities, and Planned Deviations, as well as participating in Notified Body audits and inspections.
Key Responsibilities- Drive global R&D project activities as QM lead, ensuring compliance with regulatory requirements.
- Take ownership of and lead Risk Management activities within R&D projects.
- Act as Contact person related to requirements for basic safety and essential performance.
- Monitor and handle CAPA; Non-conformities; Planned Deviations.
- Participate in Notified Body audits and inspections by authorities.
- A relevant academic background (BSc/MSc).
- At least 5 years' experience working within a 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 (e.g., ISO13485, EU MDR, MDSAP, UK MD).
- Ideally, knowledge in IEC 62304.
- PASSION FOR QUALITY AND FOCUS ON QM BUSINESS PARTNERING WITH THE ORGANIZATION.
We are looking for an outgoing and confident individual with a good business understanding and excellent communication skills. You should be self-driven, like to take the lead, and work independently. Our ideal candidate is open-minded, sees possibilities even in dynamic and hectic situations, and takes pride in collaboration.
About Ambu A/SAmbu A/S has been bringing solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on our efficiency, safety, and performance. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals.
