At a Glance
- Tasks: Lead quality activities and ensure compliance in a dynamic medical device manufacturing environment.
- Company: Established medical device manufacturer with a focus on quality and innovation.
- Benefits: Competitive contract rate, hands-on leadership role, and opportunity to drive quality culture.
- Other info: Fast-paced environment with opportunities for professional growth and mentorship.
- Why this job: Make a real impact in healthcare by ensuring top-notch quality in life-saving devices.
- Qualifications: Strong background in Quality within medical devices and senior QA leadership experience.
The predicted salary is between 60000 - 80000 £ per year.
Contract Opportunity: Quality Manager (Medical Devices)
We're supporting an established medical device manufacturer looking to engage a Senior Quality Manager on a contract basis, with a strong focus on on-site leadership. This role will suit a hands-on QA professional who is comfortable balancing both strategic oversight and operational delivery within a regulated, high-volume manufacturing environment. You'll play a critical role in driving quality culture, ensuring compliance, and acting as a key decision-maker across site operations.
Key Responsibilities
- Lead all site Quality activities, ensuring compliance with ISO 13485, GMP, and applicable regulatory standards
- Own and continuously improve the Quality Management System (QMS), ensuring it remains audit-ready at all times
- Act as the primary Quality representative on site, working cross-functionally with manufacturing, engineering, supply chain, and leadership teams
- Drive audit readiness and lead external audits/inspections, including notified body and regulatory interactions
- Oversee CAPA, deviations, non-conformances, and root cause investigations, ensuring timely and effective closure
- Champion continuous improvement initiatives and strengthen quality culture across the site
- Provide guidance and mentorship to QA teams, fostering a high-performance environment
Requirements
- Strong background in Quality within the medical device sector (or closely related regulated industry)
- Proven experience operating in a senior, site-based QA leadership role
- In-depth knowledge of ISO 13485 and manufacturing/GMP environments
- Demonstrated experience managing audits and regulatory inspections
- Comfortable operating in fast-paced, complex manufacturing settings
- Pragmatic, solutions-driven mindset with excellent stakeholder engagement and influencing skills
Quality Manager employer: EPM Scientific
As a leading medical device manufacturer, we pride ourselves on fostering a dynamic work environment that prioritises quality and compliance. Our culture encourages hands-on leadership and continuous improvement, providing Quality Managers with the opportunity to make a significant impact while collaborating with cross-functional teams. Located in a high-volume manufacturing hub, we offer competitive benefits, professional development opportunities, and a commitment to maintaining an audit-ready Quality Management System, making us an exceptional employer for those seeking meaningful and rewarding careers in the medical device sector.