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- Tasks: Ensure product safety and quality while maintaining compliance with global regulations.
- Company: Smith+Nephew, a leader in innovative medical technology.
- Benefits: Generous bonuses, flexible vacation, health plans, and employee discounts.
- Other info: Enjoy a hybrid working model and excellent career development opportunities.
- Why this job: Make a real impact on healthcare products that improve lives.
- Qualifications: Degree in life sciences/engineering and 3+ years of relevant experience.
The predicted salary is between 40000 - 50000 £ per year.
Life Unlimited. At Smith+…we craft and manufacture technology that takes the limits off living!
You will be responsible for ensuring the safety, performance and quality of existing products for SNM conform to established standards and are in compliance with all applicable global Quality System Regulations. You will 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.
- Supporting the timely review of risk management files in line with the complaints management process.
- Supporting the timely review of PMS data as part of monthly PMS trending.
- Ensuring 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.
- Applying 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.
- Working 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. Inclusion + Belonging - Committed to Welcoming, Celebrating and Thriving.
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.
Your Wellbeing: Private health and dental plans, healthcare cash plans, income protection, life assurance, and more.
Flexibility: Hybrid working model (for most professional roles).
Training: Hands‑on, team‑customized, and mentorship‑based development.
Extra Perks: Discounts on gyms and fitness clubs, salary sacrifice bicycle and car schemes, and many other employee discounts.
Senior Sustaining Design Quality Engineer (12 months FTC) 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 (12 months FTC)
✨Tip Number 1
Network like a pro! Reach out to folks in your industry on LinkedIn or at events. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Knowing their tech inside out shows you're genuinely interested and ready to contribute.
✨Tip Number 3
Practice common interview questions with a mate. The more you rehearse, the more confident you'll feel when it’s showtime!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing familiar faces!
We think you need these skills to ace Senior Sustaining Design Quality Engineer (12 months FTC)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Sustaining Design Quality Engineer role. Highlight your relevant experience and skills that align with the job description, especially around risk management and compliance with quality standards.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Mention specific experiences that demonstrate your knowledge of ISO 13485 and FDA regulations, and how you can contribute to ensuring product safety and quality.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use quantifiable results where possible to illustrate how you've positively impacted quality systems or risk management in your previous roles.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from us!
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, like ISO 13485 and FDA regulations. Being able to discuss these confidently will show that you understand the compliance landscape and are ready to ensure product safety and quality.
✨Showcase Your Experience
Prepare specific examples from your past work that demonstrate your experience with risk management and quality assurance in medical devices. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easy for the interviewer to see your impact.
✨Ask Insightful Questions
Come prepared with questions that show your interest in the role and the company. Ask about their current challenges in maintaining compliance or how they approach risk management. This not only shows your enthusiasm but also helps you gauge if the company is the right fit for you.
✨Emphasise Team Collaboration
Highlight your ability to work with cross-functional teams, especially with R&D and engineering. Discuss how you've successfully collaborated in the past to ensure design control and compliance, as this role requires working closely with various departments.