Medical Device Quality Assurance Specialist

3 weeks ago


Trowbridge, Wiltshire, United Kingdom CV Library Full time

CV Library is seeking an experienced Quality Engineer to join our Manufacturing team in the south of England. This exciting opportunity comes with a salary of £40,000-£50,000 per annum, depending on experience, plus benefits.

Job Description

As a Quality Engineer, you will be responsible for ensuring adherence to product quality requirements at contract manufacturers. Your key responsibilities will include:

  • Leading CAPA investigations and activity closure
  • Validation documentation review and approvals
  • Complaint investigations/trends
  • Internal and external audits support

You will manage changes that enhance manufacturing quality and drive quality to enable strategic success. Regular site visits to the manufacturing facilities will be required for this role.

Key Responsibilities
  • Plan and execute process validation for existing and new products
  • Ensure adherence to product quality requirements at contract manufacturer
  • Plan and execute investigations as required for material or process changes
  • Provide quality leadership and support to contract manufacturers
  • Develop and maintain risk management documentation
  • Work with Manufacturing team to maintain consistency of product with internal and external manufacturing capabilities
  • Ensure quality requirements are met as manufacturing is scaled and processes optimised for volume and cost reduction
  • Assist the Production Manager and Support specialist in the analysis of manufacturing performance, identifying opportunities for improvement
  • Key liaison with contract manufacturer for the purposes of document control, design control and CAPA management
Requirements

To be successful in this role, you will need:

  • A Bachelor's degree in a biological discipline or equivalent medical device or biopharmaceutical experience
  • Full knowledge of the development of Process Validation
  • Risk Management experience
  • CAPA and Non Conformance Report experience, supplier reporting
  • Experience in an ISO 13485 environment


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