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