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Quality Assurance Manager

4 weeks ago


Ballerup, Ballerup Kommune, Denmark Ambu Full time
Job Title: Head of Global Quality Management Operations

Ambu is seeking a highly skilled and experienced professional to lead our Global Quality Management Operations team. As Head of Global Quality Management Operations, you will be responsible for ensuring the quality and regulatory compliance of Ambu products and processes across the organization.

Key Responsibilities:
  • Develop and implement quality management systems and processes to ensure compliance with regulatory requirements.
  • Lead a team of quality professionals to monitor and improve quality performance across the organization.
  • Collaborate with cross-functional teams to identify and implement process improvements.
  • Develop and maintain quality metrics and reports to track performance and identify areas for improvement.
  • Ensure compliance with regulatory requirements, including ISO 13485 and EU MDR.
Requirements:
  • Relevant academic background, BSc/MSc/Engineer.
  • At least 2-8 years' experience working in a quality organization within Medical Devices.
  • Demonstrated experience with CAPAs, NCRs, SQM.
  • Strong knowledge of relevant regulations for medical devices, e.g., ISO 13485, EU MDR, MDSAP, UK MD.
  • Passion for quality and focus on QM business partnering with the organization.
Ambu - A Visionary and International Workplace

Ambu is a company that expands rapidly and has ambitious growth targets. We meet these 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.

We offer great opportunities for personal development, a wide range of professional, social, and financial employee benefits, exciting job challenges, and continuous professional and personal development.