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Life Unlimited. At Smith+Nephew, we craft and manufacture technology that takes the limits off living!
In the role as Senior Sustaining Design Quality Engineer you will be responsible for ensuring that the safety, performance and quality of existing products for SNM conform to established standards are in compliance with all applicable global Quality System Regulations and critically maintain & monitor the risk/benefit profile of regulatory approved devices.
What will you be doing?
1. Ensuring compliance of risk management files through the review of PMS/complaints data.
2. Ensuring that risk management files and other associated quality documentation are complete and compliant by means of review and approval, as required.
3. Support the timely review of risk management files in line with the complaints management process.
4. Support the timely review of PMS data as part of monthly PMS trending.
5. Ensure compliance to cGMP, cGDP, ISO 13485, US FDA 21 CFR Part 820 and any other applicable quality standards or regulations concerning Medicinal Products and Medical Devices
6. Apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures.
7. Ensuring compliance of design control and design change activities through the review and acceptance of design activities independently of the Product Support R&D design team and/or sustaining engineering teams.
8. Ensuring that Design History Files and other associated quality documentation are complete and compliant by means of review and approval.
9. Work with Product Support R&D and/or sustaining engineering teams to ensure verification and validation outputs meet design inputs through the creation-review-execution of test cases and participation in product risk analyses and change reviews.
What will you need to be successful?
10. Graduate with a degree in a relevant life science / engineering discipline + >3 years appropriate experience.
11. Knowledge of the requirements for and application of Risk Management for medical devices in accordance with ISO 14971 and general PMS requirements.
12. Knowledge of relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485.
13. Knowledge of issues relating to the safety and clinical use of S&N AWM products.
14. Expected Subject Matter Expert in appropriate disciplines.
15. Knowledge of working in a regulated environment.
You. Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
16. Inclusion + Belonging - Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website ;
17. Your Future: Generous annual bonus and pension schemes, Save As You Earn share options.
18. Work/Life Balance: Flexible vacation and time off, paid holidays, and paid volunteering hours.
19. Your Wellbeing: Private health and dental plans, healthcare cash plans, income protection, life assurance, and more.
20. Flexibility: Hybrid working model (for most professional roles).
21. Training: Hands-on, team-customized, and mentorship-based development.
22. Extra Perks: Discounts on gyms and fitness clubs, salary sacrifice bicycle and car schemes, and many other employee discounts.