QA Engineer

London

2 months ago

Applications closed

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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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