Details:
- Salary: £45,000 - 55,000 - Annum
- Job Type: Permanent
- Job Status: Full-Time
- Salary Per: Annum
- Location: Swindon Wiltshire
- Date: 1 day ago
Description:
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