At a Glance
- Tasks: Execute global risk management processes and ensure compliance across product lifecycles.
- Company: Join a leading company in the medical device industry focused on quality and innovation.
- Benefits: Enjoy competitive pay, 25 days holiday, wellness support, and career development opportunities.
- Other info: Collaborate with diverse teams and enjoy a supportive culture for personal growth.
- Why this job: Make a real impact by ensuring product safety and compliance in a dynamic environment.
- Qualifications: 3+ years in Quality/Design roles and strong knowledge of risk management standards.
The predicted salary is between 40000 - 50000 £ per year.
Department: Quality Assurance
Location: Office based – Chandlers Ford (Moving to Southampton September 2026)
Working Hours: Monday – Friday, 8:30-4:30
Job Summary: You are responsible for executing Risk Management processes globally and across the product lifecycle – from design and development through manufacturing, commercialization, and post‑market – ensuring that all risks are identified and that risk controls are implemented, effective, and compliant with global regulations and standards. You will partner closely with Quality, Regulatory, R&D, Clinical/Medical, and Operations to drive risk‑informed decision‑making and inspection readiness. The role also involves interfacing externally with auditing/certifying bodies and vendors.
Essential Functions & Accountabilities:
- Leadership & Governance: Perform as an individual contributor. Champion the RMO initiatives and promote quality culture across the enterprise.
- Lifecycle Risk Management: Perform activities that support the maintenance and change control of Risk Management Files (RMFs) through the product lifecycle. Ensure hazard and harm identification, severity/occurrence/detection scoring, risk controls, and risk benefit analysis are consistently applied and justified. Ensure integration of risk management within Design Controls and QMS processes (e.g., CAPA, NC, Change Control, SCAR, Complaints, HHE).
- Compliance & Inspection Readiness: Ensure global alignment to applicable standards and regulations (ISO 14971, ISO 10993, ISO 13485, IEC 62366, EU MDR, FDA QSR, ICH Q9/QRM, etc.). Support audit and inspection readiness (internal, notified body, health authority). Support updates to risk management procedures and training deployment as required.
- Data, Analytics & Post‑Market Surveillance: Support data gathering for risk system dashboards and KPIs/leading indicators analysis to proactively identify emerging risks. Partner with Data/IT to enable digital tools for risk assessments, traceability, and evidence management.
- Cross‑Functional Collaboration & Training: Build strong partnerships with QA Ops, Manufacturing, Engineering, R&D, Regulatory, Clinical/Medical Affairs, and Supply Chain to embed risk thinking. Support development and deployment of global training/certification for risk methodologies and tools.
- Continuous Improvement: Support simplification initiatives to improve clarity and reduce cycle time without compromising compliance. Support identification and deployment of best practices and system maturity initiatives.
- Design Control: Provide guidance and support to the business for design control processes and projects when required.
- Travel Requirements: Up to 5 % (approximately 3 weeks per year).
Knowledge, Skills & Abilities: Demonstrated expertise with risk tools/methods and associated documentation. Strong working knowledge of risk standards and regulations (ISO 14971, ISO 13485, IEC 62366, ISO 10993, EU MDR, FDA QSR, ICH Q9) and QMS processes (Design Controls, CAPA, NC, Change Control). Strong communication skills with ability to work across different functions, teams, and cultures.
Experience & Education: 3 + years of experience working in Quality/Design and Development within regulated industries such as medical devices, pharma, diagnostics, or combination products, applying 21 CFR 820, ISO 13485, MDR and ISO 14971 requirements. 2 + years of experience in risk‑management SME roles applying ISO 14971, ISO 10993 and IEC 62361. Experience effectively working with multiple sites, time zones, and cultures. Bachelor’s degree in Engineering, Life Sciences, Quality, or a related field.
What We Offer: Competitive compensation and a comprehensive benefits package, including 25 days holiday, pension scheme, access to our Wellness Platform for mental health and wellbeing, discounted contact lens scheme, and more. We are committed to employees’ personal and professional development and offer extensive training to support career growth.
EEO Statement: All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.
Quality Engineer – Global Risk Management Office in Eastleigh employer: CooperVision
At CooperVision, we pride ourselves on being an exceptional employer, offering a dynamic work environment in Chandlers Ford, soon to be Southampton, where innovation and quality are at the forefront of our mission. Our commitment to employee growth is evident through extensive training opportunities and a comprehensive benefits package that includes 25 days of holiday and access to wellness resources, fostering a culture of support and collaboration across all levels. Join us to make a meaningful impact in the global risk management landscape while enjoying a fulfilling career in a company that values your contributions.
