Quality Assurance Engineer

2 weeks ago


Ballerup, Ballerup Kommune, Denmark Ambu Full time

Are you passionate about quality and compliance in the Medical Device industry? As Head of Global Quality Management Operations, you will lead a team of 8 talented QM professionals to ensure quality and regulatory compliance of Ambu products and processes across the organization.

Key Responsibilities

In this role, you will be responsible for:

  • Assessing supplier quality for sterilization services
  • Supporting PMS, trending, and monitoring activities
  • Developing and optimizing the Quality Management System and Processes
  • Performing training in general compliance processes
  • Improving the Quality System Performance within QA Processes
  • Participating in global quality fora to discuss proactive process improvement
  • Supporting other processes and tasks within QAE Compliance & SQM
  • Performing or supporting Quality Audits (Internal/External/Suppliers) according to audit plan or on request

Suggested Candidate Profile

For this role, you will need a relevant academic background and at least 5-10 years' experience working in a quality organization or sterility control within Medical Devices. You should have strong knowledge of relevant regulations for medical devices, such as ISO13485, EU MDR, MDSAP, and UK MD, as well as a passion for quality and focus on QM business partnering with the organization.



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