At a Glance
- Tasks: Ensure quality and regulatory compliance for innovative orthopaedic medical devices.
- Company: Fast-growing UK medical device company with a focus on custom solutions.
- Benefits: Competitive salary, pension, fully remote work, and flexible hours.
- Other info: Great opportunities for professional development in a dynamic environment.
- Why this job: Take ownership of exciting projects and make a real difference in healthcare.
- Qualifications: Bachelor's degree and 3-5 years' QA/RA experience in medical devices.
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
QARA Specialist in Swindon employer: GxPeople Global
As a leading healthcare technology and diagnostics company, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to make a meaningful impact in the medical field. Our commitment to professional development ensures that you will have ample opportunities for growth while working on cutting-edge diagnostic devices in a supportive environment located in the UK. Join us to be part of a mission-driven team dedicated to improving patient outcomes through advanced technology.
