Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
Are you passionate about quality? This position Engineer is responsible for implementing, supporting, and sustaining elements of Smith and Nephew’s quality system. Under the guidance and direction of the Design Quality Engineering Manager, he/she ensures that medical device regulations, standards, and guidelines are complied with through execution of Smith and Nephew procedures. The Design Quality Engineer determines methods, techniques, and evaluation criteria for medical devices. He/she serves as a key resource for ISO, EN, MDD, EU MDR, and QSR requirements.
This position is a P1 level
What will you be doing?
- Generate change records necessary for compliance to latest regulatory requirements (e.g. GMP’s, ISO 13485, ISO 14971, MDD, EU MDR, etc.).
- Provide quality oversight and leadership for product cutover to assure these are managed effectively.
- Work with suppliers to ensure compliance to latest regulatory requirements (e.g. GMP’s, ISO 13485, ISO 14971, MDD, EU MDR, etc.) changes have been implemented.
- Support Management Review, and internal and external audits/inspections.
- Assist in other responsibilities requested by management to ensure compliance.
What will you need to be successful?
- Education: Bachelor’s degree in engineering or related field.
- Languages: Advanced English level.
- Experience: Minimum 1 year of experience in the medical device or related industry.
- Competencies: Able to make sound decisions with attention to details.
- Understanding the impact of regulatory requirements (e.g. GMP’s, ISO 13485, ISO 14971, MDD, EU MDR, etc.) on Smith & Nephew’s products is necessary
- Able to provide and implement solutions to quality problems.
- Ability to plan and schedule multiple projects and tasks.
- Effective written/oral communication skills.
- Team player.
- MS Office, MS Excel, and Statistical software proficiency.
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 Thriving on Diversity, Learn more about Employee Inclusion Groups on our website.
Other reasons why you will love it here!
- Your future: stock purchase program, referral bonus, subsidy in transport and food, recognition program.
- Work/Life Balance: Extra days off, birthday off, voluntary hours.
- Your Wellbeing: company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave.
- Flexibility: Hybrid work model (for more professional roles), flexible schedules.
- Training: Training program, unlimited learning.
- Extra perks: employees association, and more…
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Smith & Nephew Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Smith & Nephew and has not been reviewed or approved by Smith & Nephew.
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Healthcare Strength — Medical, dental, and vision plans are paired with a global mental‑health program for employees and families, indicating a robust core health package.
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Retirement Support — U.S. employees have access to a 401(k) with company contributions, and share plans complement long‑term savings.
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Leave & Time Off Breadth — Generous holiday, paid volunteering leave, and flexible work models point to broad time‑off options.
Smith & Nephew Insights
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What We Do
Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude, we work together to win.. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited. Please note: not all products referred to may be approved for use or available in all markets.
