The Quality Assurance Officer is responsible for all quality activities across the full life-cycle of a product/products within a market sector, ensuring full compliance against relevant quality standards. This position is based within the medical strategic business unit.
- The QA Officer leads on project teams to ensure quality assurance compliance for relevant products and services across their full life cycle.
- Approving product batch releases from a Quality remit.
- Defining, managing and implementing plans to achieve quality assurance compliance for relevant products.
- Managing customer complaints, corrective and preventative actions and root cause investigations.
- Planning, implementing and reporting validation activities both internally and in collaboration with suppliers and/or customers.
- Collation, submission and maintenance of Master Files and Technical Files to enable and support registration of products.
- Participating in and supporting all audits (internal, supplier, customer and regulatory).
- Liaison with internal and external customers and suppliers in support of quality assurance compliance activities and queries including impact on product use.
Experience operating in a highly regulated industry
Experience of quality management systems for relevant market sectors
Experience of the auditing process in a regulated industry (ISO 13485, MDD and FDA QSR)