Quality Assurance Manager
4 days ago
We are currently seeking a highly skilled Quality Assurance Manager to join our team in Sweden. As a key member of our organization, you will be responsible for leading the site QA team and ensuring that all quality management systems (QMS) processes are compliant with relevant regulatory requirements.
This role is ideal for an experienced professional with a strong background in quality assurance and regulatory compliance within the medical device industry. You will have the opportunity to develop and manage local QA teams, support the organization in continuously improving the quality of products and QMS, and oversee operational activities such as reviewing and approving quality documents.
Key responsibilities include:
- Leading the site Quality Team
- Serving as Person Responsible for Regulatory Compliance (PRRC) where the site is the legal manufacturer
- QA support for site functions including Operation, Production, Supply Chain, R&D including design and development
- Ensuring assigned QMS processes are compliant with all applicable regulatory requirements for medical devices (Class I EMA & Class II US) in accordance with MDR 2017/745, ISO13485, and FDA cGMP regulations 21 CFR part 820
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