At a Glance
- Tasks: Lead global risk management processes and ensure compliance across product lifecycles.
- Company: Join a leading medical device company focused on innovation and quality.
- Benefits: Competitive salary, 25 days holiday, wellness platform, and LinkedIn Learning access.
- Other info: Opportunity for career growth and continuous improvement in a dynamic environment.
- Why this job: Make a real impact in risk management while collaborating with diverse teams.
- Qualifications: 6+ years in Quality/Design and 4+ years in Risk Management roles required.
The predicted salary is between 60000 - 80000 £ 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 will be responsible for executing and providing oversight of 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 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 with minimal supervision.
- Support/coach junior members of the RMO team.
- Act as deputy for the Manager Global RMO as required.
- Lifecycle Risk Management
- Maintain and control Risk Management Files (RMFs) throughout the product lifecycle.
- Apply hazard and harm identification, severity/occurrence/detection scoring, risk controls and risk benefit analysis consistently and justify outcomes.
- Integrate Risk Management within Design Controls and QMS processes (CAPA, NC, Change Control, SCAR, Complaints, HHE) and support regulatory submissions/renewals.
- 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).
- Drive audit/inspection readiness for internal, notified body, and health authority inspections.
- Monitor and interpret evolving global regulations and update procedures and training accordingly.
- Data, Analytics & Post‑Market Surveillance
- Maintain risk system dashboards, KPIs, leading indicators, and trending methodologies 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 partnerships with QA Ops, Manufacturing, Engineering, R&D, Regulatory, Clinical/Medical Affairs, and Supply Chain to embed risk thinking.
- Support and lead development and deployment of global training and certification for risk methodologies and tools; mentor and coach regional risk leaders.
- Continuous Improvement
- Lead external benchmarking, deployment of best practices, and periodic maturity assessments of the risk system.
- Lead simplification initiatives to improve clarity and reduce cycle time without compromising compliance.
- Design Control
- Provide guidance and support for design control processes and projects where required.
- Travel Requirements
- 5–10% (3 to 5 weeks per year).
- Knowledge, Skills and Abilities
- Expertise with risk tools/methods and associated documentation.
- Strong 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 functions, teams, and cultures.
- Experience and Education
- 6+ years 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.
- 4+ years 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 related field; Master’s degree preferred.
- Benefits
- Competitive compensation and a comprehensive benefits package including bonus, 25 days holiday, pension scheme, wellness platform, discounted contact lens scheme, and LinkedIn Learning access.
All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.
Principal Quality Engineer – Global Risk Management Office in Hampshire employer: CooperVision Limited
At CooperVision, we pride ourselves on being an exceptional employer, offering a dynamic work environment in Chandlers Ford with plans to move to Southampton in 2026. Our culture fosters collaboration and continuous improvement, providing employees with ample opportunities for professional growth through mentorship and training initiatives. With competitive compensation, a comprehensive benefits package, and a commitment to employee well-being, we ensure that our team members are supported both personally and professionally as they contribute to meaningful projects in the global risk management landscape.
