Quality Assurance Director
1 month ago
This is a senior leadership position within our Quality Management team, responsible for ensuring the quality and regulatory compliance of Ambu products and processes across the organization.
About the JobWe are seeking a highly experienced and skilled individual to lead our global quality operations. The successful candidate will be part of a stellar team consisting of 8 talented QM professionals.
Main Responsibilities- Support to CAPA/NCR Process and drive CAPA/NCR initiatives
- Support to Planned deviations and complaint handling
- Perform training in general compliance processes and overall improvement of the Quality System Performance within QA Processes
- Participate in global quality fora to discuss proactive process improvement and support other processes and tasks within QAE Compliance & SQM
- Perform or support Quality Audits (Internal/External/Suppliers) according to audit plan or on request
The ideal candidate will have:
- A 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
- A passion for quality and focus on QM business partnering with the organization
Ambu offers great opportunities for personal development and 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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