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.

Key responsibilities

• 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

Essential requirements:

• 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

Desirable

• IEC 62304 software validation or SaMD experience

• Additive manufacturing process control knowledge

• Fluency in a second language

Package:

• £45,000–£55,000 base salary

• Pension and benefits

• Fully remote with flexible hours

• Strong professional development