Principal Quality Engineer - Global Risk Management Office

Job title: Principal Quality Engineer – Global Risk Management Office

Department: Quality Assurance

Location: Office based -Chandlers Ford (Moving to Southampton September 2026)

Working Hours: Monday – Friday, 8:30-4:30

A brighter future awaits you

CooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. It’s more than making contact lenses, it’s about giving lens wearers freedom and confidence to move about their daily lives. We’re all about bright futures – for our people and those who wear our contact lenses.

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.
• Can act as depute for the Manager Global RMO (as required).

Lifecycle Risk Management:

• Responsible for maintenance and change control of Risk Management Files (RMFs) for product lifecycle.
• Ensure hazard and harm identification, severity/occurrence/detection scorings, risk controls and risk benefit analysis are consistently applied and justified.
• Ensure integration of Risk Management within Design Controls, QMS processes (e.g. CAPA, NC, Change Control, SCAR, Complaints, HHE), and in support of regulatory submissions/renewals.

Compliance & Inspection Readiness:

• Ensure global alignment to applicable standards and regulations (e.g., ISO 14971, ISO10993, ISO 13485, IEC 62366, EU MDR, FDA QSR/Quality Management System Regulation, ICH Q9/QRM as applicable).
• Drive audit/inspection readiness (internal, notified body, health authority).
• 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 strong partnerships with QA Ops, Manufacturing, Engineering, R&D, Regulatory, Clinical/Medical Affairs, and Supply Chain to embed risk thinking.
• Support/lead the develop and deployment of global training/certification for risk methodologies and tools; mentor/coach regional risk leaders.

Continuous Improvement:

• Support/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:

• Where required, provide guidance and support to the business for design control processes and projects.

Travel Requirements

• 5 - 10% (3 to 5 weeks per year)

Knowledge, Skills And Abilities

• Demonstrated expertise with risk tools/methods and associated documentation.
• Strong working knowledge of risk standards and regulations (e.g., ISO14971/ ISO13485/ IEC62366, ISO10993, EU MDR, FDA QSR/QMSR, 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 And Education

• 6+ years of experience working in Quality/Design and Development within regulated industries such as medical devices/pharma/diagnostics/combination products and applying 21 CFR 820, ISO 13485, MDR and ISO14971 requirements.
• 4+ years of experience in Risk Management SME roles applying ISO14971, ISO10993 and IEC62361.
• Experience in effectively working with multiple sites, time zones, and cultures.
• Bachelor’s degree in Engineering, Life Sciences, Quality, or related field; Master’s degree preferred.

What we offer

You’ll receive competitive compensation and a fantastic benefits package including: bonus, 25 days holiday, pension scheme, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more!

We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals, we’ll give you everything you need to help you achieve yours.

We also provide access to LinkedIn Learning to help you develop in your career and grow with CooperVision

What you can expect

As a CooperVision employee, you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering an inclusive culture is and how different perspectives add value and contribute to our success.

If you like what you see, take the first step towards your Brighter Future and apply today! All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.

Please view our careers page at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1 to view all other opportunities.