QARA Specialist

QA/RA Specialist
- Orthopaedic Medical Devices
- Remote (UK) - £45,000-£55,000

GxPeople is recruiting a QA/RA Specialist for an innovative UK medical device company that specialises in custom-made orthopaedic devices. The business is growing fast and launching a range of CE-marked implantable devices. This is a remote role with real ownership, from product development through to market release.

• Maintain and secure ISO 13485, CE and EU MDR approvals
• Manage internal and external audits
• Own and run the CAPA process
• Support new product development, including manufacturing process control and additive manufacturing
• Draft and maintain procedures, work instructions, plans and reports
• Promote a strong culture of quality and best practice

• Bachelor's degree in a scientific, engineering, regulatory, quality or legal discipline
• 3-5 years' QA/RA experience within surgical or orthopaedic medical devices
• In-depth knowledge of ISO 13485, ISO 14971, CE marking, EU MDR and FDA 510(k)
• Experience with QMS software
• Excellent written communication and problem-solving skills

• IEC 62304 software validation or SaMD experience
• Additive manufacturing process control knowledge
• Fluency in a second language

• £45,000-£55,000 base salary
• Pension and benefits
• Fully remote with flexible hours
• Strong professional development