Head of Global Quality Management Operations

2 months ago


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

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

Key Responsibilities:
  • Develop and optimize the Quality Management System and Processes within your team's area of responsibility.
  • Support to CAPA/NCR Process and responsible for driving CAPA/NCR.
  • Support to Planned deviations.
  • Support to Complaint handling and Complaint Process.
  • Support to PMS, trending and monitoring activities.
  • Perform training in general compliance processes.
  • Overall improvement of 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 where your efforts matter

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. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.



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