At a Glance
- Tasks: Execute global Risk Management processes across the product lifecycle and ensure compliance with regulations.
- Company: Join a diverse and progressive global business at CooperVision.
- Benefits: Enjoy competitive pay, 25 days holiday, wellness support, and a pension scheme.
- Other info: Collaborate with cross-functional teams and enjoy excellent career growth opportunities.
- Why this job: Make a real impact in quality assurance and risk management in the medical field.
- 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
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!
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. All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.
Quality Engineer – Global Risk Management Office in Eastleigh employer: CooperVision Limited
CooperVision is an exceptional employer, offering a dynamic work environment in Chandlers Ford, soon to be Southampton, where you can thrive as a Quality Engineer in the Global Risk Management Office. With a strong commitment to employee wellbeing, competitive benefits including 25 days holiday and a wellness platform, and a culture that values diversity and inclusion, CooperVision fosters professional growth and collaboration across various functions, making it an ideal place for those seeking meaningful and rewarding careers.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer – Global Risk Management Office in Eastleigh
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like CooperVision Limited looking for candidates who are engaged and informed.
We think you need these skills to ace Quality Engineer – Global Risk Management Office in Eastleigh
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at CooperVision Limited. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at CooperVision Limited
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with CooperVision Limited’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
