Quality Assurance Manager

1 month ago


Ballerup, Ballerup Kommune, Denmark Ambu Full time
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 optimize the Quality Management System and Processes within the team's area of responsibility.
  • Support the CAPA/NCR Process and drive CAPA/NCR initiatives.
  • Support Planned deviations, Complaint handling, and Complaint Process.
  • Support PMS, trending, and monitoring activities.
  • Perform training in general compliance processes.
  • Improve the Quality System Performance within QA Processes.
  • Participate in global quality fora to discuss proactive process improvement.
  • Support other processes and tasks within QAE Compliance & SQM.
  • Perform or support Quality Audits (Internal/External/Suppliers) according to audit plan or on request.
  • Responsible for Quality Assurance input to Supplier Controls: Evaluation; Monitoring; Re-evaluation.
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., ISO13485, 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.



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