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Site Manager QA
2 weeks ago
About the Job:
We are seeking a Site Manager QA to join our team in TN Sweden. As a key member of our quality management system, you will be responsible for ensuring that our medical devices meet the highest standards of quality and regulatory compliance.
Key Responsibilities:
- Lead the site QA team
- PRRC (where the site is the legal manufacturer)
- QA support for site functions including Operation, Production, Supply Chain, R&D
- Ensure that assigned QMS processes are compliant with all applicable regulatory requirements for medical devices
Requirements:
- Masters or Bachelor's degree in science and engineering
- Good knowledge of quality systems, quality assurance, and regulatory standards within the Medical Device industry
- At least 5 years of working experience in a similar role
- Ability to be PRRC for products (where the site is the legal manufacturer)
- Previous experience of ensuring QMS processes are compliant with all applicable regulatory requirements for medical devices
- Fluent in English and Swedish both oral and written
