At a Glance
- Tasks: Lead global risk management processes and ensure compliance across product lifecycles.
- Company: Join CooperVision, a top manufacturer of soft contact lenses with a global presence.
- Benefits: Enjoy competitive pay, 25 days holiday, wellness support, and career development opportunities.
- Other info: Be part of a diverse team committed to personal and professional growth.
- Why this job: Make a real impact in improving vision and enhancing lives through innovative risk management.
- Qualifications: 6+ years in Quality/Design roles, strong knowledge of risk standards, and excellent communication skills.
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
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.
Principal Quality Engineer – Global Risk Management Office in Eastleigh employer: CooperCompanies
CooperVision is an exceptional employer that prioritises the growth and well-being of its employees, offering a competitive benefits package including generous holiday allowance, a pension scheme, and access to wellness resources. With a commitment to fostering a diverse and inclusive work culture, employees are encouraged to develop their skills through extensive training and resources like LinkedIn Learning, ensuring a meaningful career path in a supportive environment. Located in Chandlers Ford, soon moving to Southampton, this role provides the opportunity to be part of a global leader in the contact lens industry, contributing to innovative solutions that enhance people's daily lives.
StudySmarter Expert Advice🤫
We think this is how you could land Principal Quality Engineer – Global Risk Management Office in Eastleigh
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at CooperVision. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by knowing your stuff. Brush up on risk management processes and relevant regulations. Show them you’re not just a candidate, but the right fit for their team!
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can keep you fresh in their minds and show your enthusiasm for the role.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining the CooperVision family.
We think you need these skills to ace Principal Quality Engineer – Global Risk Management Office in Eastleigh
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the Principal Quality Engineer role. Highlight your expertise in risk management and quality assurance, and don’t forget to mention any relevant certifications or training.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to tell us why you’re passionate about quality engineering and how your background makes you a perfect fit for our team. Be sure to mention specific projects or achievements that demonstrate your capabilities.
Showcase Your Collaboration Skills:Since this role involves working closely with various teams, make sure to highlight your experience in cross-functional collaboration. Share examples of how you've successfully partnered with different departments to achieve common goals.
Apply Through Our Website:We encourage you to apply directly through our careers page. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details about the role and other opportunities we have available!
How to prepare for a job interview at CooperCompanies
✨Know Your Risk Management Standards
Familiarise yourself with key risk management standards like ISO 14971 and ISO 13485. Be prepared to discuss how you've applied these in your previous roles, as this will show your expertise and understanding of the regulatory landscape.
✨Showcase Cross-Functional Collaboration
Highlight your experience working with various teams such as Quality, R&D, and Operations. Prepare examples that demonstrate your ability to build strong partnerships and drive risk-informed decision-making across departments.
✨Prepare for Compliance Questions
Expect questions about compliance and inspection readiness. Brush up on your knowledge of global regulations and be ready to explain how you ensure alignment with these standards in your work.
✨Demonstrate Continuous Improvement Mindset
Be ready to discuss how you've led or supported continuous improvement initiatives in your past roles. Share specific examples of how you've simplified processes or implemented best practices to enhance risk management.
