Quality Engineer – Medical Devices
South of England – Hybrid (minimum 3 days onsite)
Salary £40000-£5000 + benefits depending on experience
A medical device company in the south of England is seeking an experienced Quality Engineer to join the Manufacturing team at an exciting time of rapid growth.
As a Quality Engineer you’ll act as the authority in the quality management system requirements and product. This diverse role includes:
1. Non-conformance management
2. Leading CAPA investigations and activity closure
3. Validation documentation review and approvals
4. Complaint investigations/trends
5. Internal and external audits support
You will manage changes that enhance manufacturing quality and drive quality to enable strategic success and suggest innovative solutions to technical problems. Regular site visits to the manufacturing facilities will be required for this role.
Responsibilities:
1. Plan and execute process validation for existing and new products
2. Ensure adherence to product quality requirements at contract manufacturer
3. Plan and execute investigations as required for material or process changes
4. Provide quality leadership and support to contract manufacturers
5. Develop and maintain risk management documentation
6. Work with Manufacturing team to maintain consistency of product with internal and external manufacturing capabilities
7. Ensure quality requirements are met as manufacturing is scaled and processes optimised for volume and cost reduction
8. Assist the Production Manager and Support specialist in the analysis of manufacturing performance, identifying opportunities for improvement
9. Key liaison with contract manufacturer for the purposes of document control, design control and CAPA management
Experience and Skills Required:
1. A Bachelor's degree in a biological discipline or equivalent medical device or biopharmaceutical experience
2. Full knowledge of the development of Process Validation
3. Risk Management experience
4. CAPA and Non Conformance Report experience, supplier reporting
5. Experience in an ISO 13485 environment
How to Apply:
Applicants excited about contributing to the advancement of healthcare and meeting the qualifications are encouraged to submit their CV (in MS Word format ideally please) to Julie Harding at X4 Life Sciences: (url removed)
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