At a Glance
- Tasks: Execute global Risk Management processes and ensure compliance across the product lifecycle.
- Company: Join CooperVision, a leading manufacturer of soft contact lenses with a global presence.
- Benefits: Enjoy competitive pay, 25 days holiday, wellness support, and career development opportunities.
- Other info: Access to LinkedIn Learning and a commitment to personal and professional growth.
- Why this job: Make a real impact on product safety and quality while working in a diverse team.
- Qualifications: 3+ years in Quality/Design within regulated industries and strong risk management expertise.
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
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 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 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: Responsible for performing activities that support the 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 and QMS processes (e.g. CAPA, NC, Change Control, SCAR, Complaints, HHE).
- 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). Support audit/inspection readiness (internal, notified body, health authority). Support update of 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 the 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 the identification and deployment of best practices and system maturity initiatives.
- Design Control: Where required, provide guidance and support to the business for design control processes and projects.
Travel Requirements: Up to 5% (~3 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: 3+ 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. 2+ 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.
What we offer: You’ll receive competitive compensation and a fantastic benefits package including 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.
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 25 days holiday, a pension scheme, and access to wellness resources. With a commitment to fostering an inclusive and diverse work culture, employees are encouraged to develop their skills through extensive training and resources like LinkedIn Learning, ensuring a meaningful career path in a globally recognised company dedicated to improving lives through innovative contact lens solutions.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer – Global Risk Management Office in Eastleigh
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already working at CooperVision. A friendly chat can open doors and give you insider info on the company culture and what they really value.
✨Tip Number 2
Prepare for the interview by knowing your stuff! Brush up on risk management processes and relevant regulations like ISO 14971 and FDA QSR. Show us you’re not just a candidate, but someone who’s genuinely excited about making a difference in quality assurance.
✨Tip Number 3
Practice your STAR technique for answering behavioural questions. We want to hear about specific situations where you’ve demonstrated your skills in risk management or cross-functional collaboration. Make it memorable!
✨Tip Number 4
Don’t forget to follow up after your interview! A quick thank-you email can leave a lasting impression. It shows you’re keen and professional, which is exactly what we love to see at CooperVision.
We think you need these skills to ace Quality Engineer – Global Risk Management Office in Eastleigh
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Engineer role. Highlight your experience with risk management and quality assurance, and don’t forget to mention any relevant certifications or standards you’re familiar with!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality engineering and how your skills align with our mission at CooperVision. Keep it concise but impactful!
Showcase Your Collaboration Skills:Since this role involves working closely with various teams, make sure to highlight your collaboration skills. Share examples of how you’ve successfully partnered with others in past roles to drive quality initiatives.
Apply Through Our Website:We encourage you to apply through our website for the best chance of being noticed. It’s super easy, and you’ll be able to see all the opportunities we have available. Don’t miss out on your brighter future with us!
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 industry.
✨Showcase Cross-Functional Collaboration
Highlight your experience working with different teams such as Quality, R&D, and Operations. Prepare examples of how you’ve successfully collaborated across functions to drive risk-informed decision-making.
✨Prepare for Compliance Questions
Expect questions about compliance and inspection readiness. Brush up on relevant regulations like EU MDR and FDA QSR, 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 contributed to continuous improvement initiatives in your past roles. Share specific examples of how you've simplified processes or identified best practices that enhanced compliance without compromising quality.
