Global Quality Assurance Leader for Medical Devices

1 week ago


Ballerup, Ballerup Kommune, Denmark Ambu AS Full time
About the Role

We are seeking a highly skilled and experienced Global Quality Assurance Leader to join our team at Ambu A/S. In this role, you will be responsible for leading global R&D project activities, taking ownership of risk management, and ensuring compliance with relevant regulations.

Key Responsibilities
  • Drive global R&D project activities as QM lead, focusing on quality assurance and regulatory compliance.
  • Lead Risk Management activities within R&D projects, identifying and mitigating potential risks.
  • Act as a contact person for basic safety and essential performance requirements, ensuring seamless communication with stakeholders.
  • Handle and monitor CAPA, Non-conformities, and Planned Deviations, implementing corrective actions as needed.
  • Participate in Notified Body audits and inspections by authorities, demonstrating expertise and confidence.
Suggested Candidate Profile

We envision an ideal candidate possessing:

  • A relevant academic background, preferably BSc/MSc in a field related to quality management or medical devices.
  • At least 5 years' experience working within a quality organization for medical devices, showcasing expertise in IEC 60601 and ISO 14971.
  • In-depth knowledge of relevant regulations, including ISO13485, EU MDR, MDSAP, and UK MD, with a strong passion for quality and focus on QM business partnering.
  • Ideal candidates should possess knowledge in IEC 62304, highlighting their commitment to excellence and innovation.
About Ambu A/S

Ambu has been a pioneer in delivering innovative quality products since 1937. Our single-use endoscopy, anesthesia, and patient monitoring solutions have transformed patient care worldwide. Headquartered in Denmark, we employ approximately 4,500 people across Europe, North America, and the Asia Pacific.

Compensation and Benefits

We offer a competitive salary of approximately €80,000 - €110,000 per annum, commensurate with experience and qualifications. Additionally, our employees enjoy a wide range of benefits, including professional growth opportunities, a dynamic work environment, and access to cutting-edge technology.



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