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- Tasks: Ensure product safety and quality compliance while reviewing risk management files and documentation.
- Company: Smith+Nephew crafts innovative medical technology to enhance lives globally.
- Benefits: Enjoy flexible working, generous bonuses, health plans, and discounts on fitness memberships.
- Why this job: Join a mission-driven team focused on innovation and making a positive impact on society.
- Qualifications: Degree in life sciences/engineering with over 3 years of relevant experience required.
- Other info: Hybrid working model available; we celebrate diversity and inclusion in our workplace.
The predicted salary is between 43200 - 72000 £ per year.
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?
- Ensuring compliance of risk management files through the review of PMS/complaints data.
- Ensuring that risk management files and other associated quality documentation are complete and compliant by means of review and approval, as required.
- Support the timely review of risk management files in line with the complaints management process.
- Support the timely review of PMS data as part of monthly PMS trending.
- 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
- Apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures.
- 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.
- Ensuring that Design History Files and other associated quality documentation are complete and compliant by means of review and approval.
- 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?
- Graduate with a degree in a relevant life science / engineering discipline + >3 years appropriate experience.
- Knowledge of the requirements for and application of Risk Management for medical devices in accordance with ISO 14971 and general PMS requirements.
- Knowledge of relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485.
- Knowledge of issues relating to the safety and clinical use of S&N AWM products.
- Expected Subject Matter Expert in appropriate disciplines.
- 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.
- Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Growing on Diversity, Learn more about our Employee Inclusion Groups on our website
- Your Future: Generous annual bonus and pension Schemes, Save As You Earn share options.
- Work/Life Balance: Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!
- Your Wellbeing: Private Health and Dental plans, Healthcare Cash Plans, Income Protection, Life Assurance and much more.
- Flexibility: Hybrid Working Model (For most professional roles).
- Training: Hands-On, Team-Customised, Mentorship.
- Extra Perks: Discounts on Gyms and fitness clubs, Salary Sacrifice Bicycle and Car Schemes and many other Employee discounts.
Applications:
If you share our passion for pioneering innovation and can demonstrate how you meet the criteria outlined, we would love to hear from you.
We continue to actively build an environment where every individual can fulfil their potential and be proud ambassadors for Smith & Nephew, our customers and their patients.
We value the diversity of our people and welcome applications from everyone.
#LI-hybrid #LI-KK1
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Senior Sustaining Design Quality Engineer employer: Smith & Nephew
Contact Detail:
Smith & Nephew Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Sustaining Design Quality Engineer
✨Tip Number 1
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as ISO 13485 and FDA Quality System Regulation. Being able to discuss these in detail during your interview will demonstrate your expertise and commitment to quality.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in risk management and quality assurance. Engaging with them can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss real-world examples of how you've ensured compliance with quality standards in previous roles. Highlighting your hands-on experience with risk management files and design control will set you apart from other candidates.
✨Tip Number 4
Stay updated on the latest trends and challenges in the medical device sector. Showing that you're informed about current issues can help you engage in meaningful conversations during interviews and demonstrate your passion for the field.
We think you need these skills to ace Senior Sustaining Design Quality Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality engineering, particularly in the medical device sector. Emphasise your knowledge of ISO 13485 and FDA regulations, as well as any specific projects that demonstrate your expertise in risk management.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality assurance in medical devices. Mention how your background aligns with Smith+Nephew's mission and values, and provide examples of how you've successfully ensured compliance with quality standards in previous roles.
Highlight Relevant Skills: Clearly outline your skills related to risk management, design control, and quality documentation. Use specific terminology from the job description, such as 'PMS data' and 'Design History Files', to show you understand the role's requirements.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents. Check for grammatical errors, clarity, and ensure that all information is accurate. A polished application reflects your attention to detail, which is crucial for a quality engineer.
How to prepare for a job interview at Smith & Nephew
✨Know Your Standards
Familiarise yourself with the key quality standards and regulations mentioned in the job description, such as ISO 13485 and FDA 21 CFR Part 820. Being able to discuss these in detail will show your expertise and understanding of the role.
✨Demonstrate Risk Management Knowledge
Prepare to discuss your experience with risk management for medical devices, particularly in relation to ISO 14971. Be ready to provide examples of how you've applied these principles in previous roles.
✨Showcase Your Problem-Solving Skills
Think of specific instances where you identified a quality issue and how you resolved it. Highlight your analytical skills and ability to work independently, especially in reviewing design control and change activities.
✨Emphasise Team Collaboration
Since the role involves working with various teams, be prepared to discuss how you’ve successfully collaborated with R&D or engineering teams in the past. Share examples that demonstrate your ability to communicate effectively and contribute to team goals.
