Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
Step into a senior level role where your expertise will directly influence product quality and patient outcomes. As a Senior Manufacturing Quality Engineer, you will play a key role in strengthening manufacturing processes, ensuring compliance, and driving continuous improvement in a highly regulated medical device environment. Based in Mansfield, MA, this is an exciting opportunity to collaborate cross functionally and make a lasting impact.
What will you be doing?
- Lead nonconformance management and CAPA activities, including root cause investigations and implementation of corrective and preventive actions
- Partner with manufacturing and operations teams to enhance process robustness and reduce variation and defect rates
- Ensure compliance with applicable regulatory and quality standards including ISO 13485, FDA 21 CFR Part 820, and ISO 14971
- Drive continuous improvement initiatives using risk based methodologies such as PFMEA
- Support development of inspection strategies including measurement system analysis
- Perform data analysis using statistical tools to evaluate and improve process capability
- Support process validation activities including IQ, OQ, and PQ
What will you need to be successful?
Education:
- Bachelor’s degree in Engineering such as Mechanical, Biomedical, Industrial, or a related discipline
Experience:
- 3 to 5 years of experience in quality engineering within a manufacturing environment
- Experience working in a regulated industry
Knowledge:
- Strong understanding of quality systems, risk management, and statistical analysis
You. Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
- Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
- Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement
- Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
- Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
- Flexibility: Hybrid Work Model (For most professional roles)
- Training: Hands-On, Team-Customized, Mentorship
- Extra Perks: Discounts on fitness clubs, travel and more!
The anticipated base compensation range for this position is $96,750-$145,000 USD annually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate.
In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, and a variety of wellness offerings.
#LI-ONSITESmith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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Skills Required
- Bachelor's degree in Mechanical, Biomedical, Industrial Engineering or related discipline
- 3 to 5 years of quality engineering experience in a manufacturing environment
- Experience working in a regulated industry (medical device or similar)
- Knowledge of and ability to work within ISO 13485, FDA 21 CFR Part 820, and ISO 14971
- Experience leading nonconformance management and CAPA activities, including root cause investigations
- Experience with process validation activities (IQ, OQ, PQ)
- Ability to drive continuous improvement using risk-based methodologies such as PFMEA
- Experience with measurement system analysis and statistical tools for process capability analysis
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
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.
