QA Engineer

London
4 days ago
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About Us

We're a working with an exciting MedTech company dedicated to advancing orthopaedic care through innovative medical device solutions. Their products improve patient outcomes and quality of life, and we're looking for a talented QA Engineer to help us maintain the highest standards of quality and regulatory compliance.

As a QA Engineer, you'll play a critical role in ensuring our orthopaedic products meet regulatory requirements and quality standards. You'll work closely with R&D, manufacturing, and regulatory teams to maintain our Quality Management System and support our growing portfolio of cutting-edge medical devices.

Key Responsibilities

  • Support FDA and CE Mark regulatory submissions and ongoing compliance activities

  • Maintain and improve our Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards

  • Prepare for and participate in internal and external audits, including FDA inspections and Notified Body assessments

  • Review and approve quality documentation, including DHFs, DMRs, and technical files

  • Investigate non-conformances and support CAPA processes

  • Provide quality oversight for additive manufacturing processes, ensuring compliance with regulatory requirements

  • Conduct supplier audits and manage vendor quality performance

  • Support design control activities and product development projects

  • Drive continuous improvement initiatives across the quality function

    Essential Experience

  • Proven experience in a QA role within the medical device industry

  • Strong working knowledge of FDA regulations (21 CFR Part 820) and CE Mark requirements (MDR/IVDR)

  • Experience preparing for and managing regulatory audits and inspections

  • Hands-on experience implementing and maintaining a Quality Management System (ISO 13485)

  • Familiarity with additive manufacturing processes and associated quality considerations

  • Understanding of orthopaedic or implantable device regulations (desirable)

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