Manufacturing Quality Engineer 2

Posted 16 Days Ago
Be an Early Applicant
Mansfield, MA, USA
In-Office
74K-112K Annually
Junior
Healthtech • Biotech
The Role
Support and improve product and process quality in medical device manufacturing. Lead nonconformance investigations and CAPA, perform root cause analysis, apply PFMEA and statistical tools, develop inspection strategies, and support process validation (IQ/OQ/PQ). Partner with operations to reduce variation and ensure regulatory compliance.
Summary Generated by Built In

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

Are you passionate about driving quality excellence in a fast-paced manufacturing environment? As a Manufacturing Quality Engineer II, you will play a key role in ensuring our products meet the highest standards of compliance and performance, while contributing to continuous improvement initiatives that directly impact patient outcomes. This is an exciting opportunity to grow your career in a collaborative and purpose driven environment where your expertise truly makes a difference.

What will you be doing?

  • Supporting and improving product and process quality across manufacturing operations
  • Leading and supporting nonconformance investigations and CAPA activities, including root cause analysis and implementation of corrective actions
  • Partnering with manufacturing and operations teams to strengthen process robustness and reduce variation and defects
  • Applying risk-based thinking using tools such as PFMEA to identify and mitigate process risks
  • Developing and optimizing inspection strategies, including measurement system analysis
  • Performing data analysis using statistical tools such as control charts and capability analysis
  • Supporting 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:

  • 1 to 3 years of experience in quality engineering within a manufacturing environment
  • Experience working in a regulated industry

Knowledge:

  • Strong understanding of quality standards and regulations including ISO 13485 and FDA 21 CFR Part 820
  • Ability to apply statistical analysis and quality engineering principles to solve problems and drive improvements
     

The anticipated base compensation range for this position is $74,250 - $111,500 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.

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!

Smith+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.

Stay connected by joining our Talent Community.

We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.  

Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.

Explore our website and learn more about our mission, our team, and the opportunities we offer. 

 

Skills Required

  • Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, or related)
  • 1 to 3 years of experience in quality engineering within a manufacturing environment
  • Experience working in a regulated industry
  • Knowledge of ISO 13485 and FDA 21 CFR Part 820
  • Ability to apply statistical analysis and quality engineering principles (control charts, capability analysis)
  • Experience with PFMEA, measurement system analysis, and developing inspection strategies
  • Support for process validation activities including IQ, OQ, and PQ

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.

  • 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.
  • Retirement Support U.S. employees have access to a 401(k) with company contributions, and share plans complement long‑term savings.
  • 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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The Company
Andover, MA
15,318 Employees

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.

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