QA Engineer

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)