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New · posted Oct 20

Smith+Nephew · Medical Devices

Design Quality Engineer

  • Mansfield, MA
  • Hybrid
  • Full-time
  • Associate & Specialist
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Pay$74K–$112Ka year · employer provided
EmploymentFull-time
LocationMansfield, MAHybrid
LevelAssociate & Specialist
FunctionQuality AssuranceQuality
Deadline

Closes Nov 2, 2026 · 14 days left

The role

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

Are you passionate about quality, innovation, and patient safety? Do you enjoy working across functions to ensure medical devices remain safe, effective, and compliant throughout their lifecycle?

Join Smith+Nephew as a Design Quality Engineer and play a key role in supporting our Sports Medicine Joint Repair portfolio while helping improve outcomes for patients around the world.

As a Design Quality Engineer, you will partner with cross-functional teams to support sustaining engineering and lifecycle management activities, ensuring products continue to meet quality, regulatory, and business requirements.

 Before applying, please note that this position is not eligible for employer-sponsored immigration support. Applicants must be currently authorized to work in the United States and must not require S+N sponsorship now or in the future to maintain that authorization

What you need

Required Qualifications

  • Bachelor of Science degree in Engineering or a related technical discipline.
  • Minimum of 2 years of experience in the medical device industry or another regulated environment.
  • Working knowledge of: FDA Quality System Regulations (QSR) ISO 13485 ISO 14971 Design Controls Risk Management methodologies CAPA and complaint handling processes
  • Strong analytical, communication, collaboration, and problem-solving skills.
  • Ability to develop and implement solutions to complex quality challenges.

Preferred Qualificationsnice to have

  • Certified Quality Engineer (CQE).
  • Six Sigma certification.
  • Experience supporting sustaining engineering and product lifecycle management.
  • Experience participating in audits, inspections, and regulatory submissions.

Physical Demands

  • Primarily seated work with occasional light lifting.

Travel Requirements

  • Less than 10% travel.

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 Options, 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
  • Training: Hands-On, Team-Customized, Mentorship
  • Extra Perks: Discounts on fitness clubs, travel and more!

In addition to base pay, we offer competitive bonus and benefits, including medical, dental, and vision coverage, 401(k), tuition reimbursement, medical leave programs, parental leave, generous PTO, paid company holidays, 8 hours of volunteer time annually, and a variety of wellness offerings such as EAP.

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 named in this posting

What you'll do

What will you be doing?

  1. Support product lifecycle management activities, including design changes, product improvements, investigations, and quality plans.
  2. Lead and support risk management activities, including risk assessments, FMEAs, implementation of risk controls, and effectiveness reviews.
  3. Review and approve design verification and validation activities, manufacturing process changes, supplier qualifications, and process validations.
  4. Investigate complaints, nonconformances, CAPAs, post-market surveillance trends, and product risk assessments to identify root causes and drive corrective actions.
  5. Ensure compliance with Design Controls, Change Control, Risk Management, and Quality System requirements throughout the product lifecycle.
  6. Collaborate with Regulatory Affairs, R&D, Manufacturing, Operations, Clinical, Marketing, and Supplier Quality teams to support product quality and regulatory compliance.
  7. Provide technical quality guidance and influence decisions that impact product performance, compliance, and patient safety.
  8. Drive continuous improvement initiatives using quality metrics, post-market data, and operational performance insights.

Pay and benefits

$74,250 – $111,500 a year

Employer provided
How this compares

The anticipated base compensation range for this position is $74,250 to $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.

  • 401(k) matching

  • Medical, dental and vision coverage

  • Tuition reimbursement

  • Flexible vacation time off and paid holidays

  • Parental leave

  • Health Savings Account employer contribution

Where you'll work

Mansfield, MAHybridOpen in Maps (opens in a new tab)

More jobs in Mansfield, MA
Equal opportunity, accessibility and legal noticesSmith+Nephew's statements, word for word

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.

Job intelligence

The context around this role

Live data · October 20, 2026

Salary intelligence

How the pay compares

This role's midpoint is 15% above the US median for Quality Assurance roles at this level.

This roleEmployer provided

$74,250 to $111,500 a year

Associate & Specialist roles in Massachusetts10 roles publishing pay

Middle half $70,375 to $90,250, median $80,000

Associate & Specialist roles in the US172 roles publishing pay

Middle half $59,000 to $93,625, median $80,500
Annual base pay
Annual base payLowMedianHigh
This role$74,250—$111,500
Massachusetts$70,375$80,000$90,250
All US$59,000$80,500$93,625

This role: Smith+Nephew's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Quality Assurance

The general path across 895 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Smith+Nephew's own promotion track.

  1. This role

    Associate & Specialist

    Often: Quality Engineer · Quality Technician

    $81K median243 open

  2. Next step

    Senior & Principal

    Often: Quality Engineer · Senior Quality Engineer

    $120K median381 open

  3. Later

    Manager

    Often: Manager, Quality Assurance · Quality Manager

    $155K median138 open

  4. Later

    Director

    Often: Director, Quality · Associate Director, Quality Assurance

    $209K median118 open

  5. Later

    VP & Executive

    Often: AVP · Executive Director Quality, Cell & Gene Therapy

    $302K median15 open

Career resources on Quality Assurance

Skills DNA

What this role leans on

How many of the posting's 39 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 5 linesLab testing and methods: 2 linesInvestigations and CAPA: 3 linesValidation and qualification: 1 lineRegulatory submissions: 1 lineQuality systems and risk: 7 linesCollaboration and leadership: 6 linesGMPLab testingInvestigationsValidationSubmissionsQuality systemsTeamwork
  • Quality systems and risk7
  • Collaboration and leadership6
  • GMP and compliance5
  • Investigations and CAPA3
  • Lab testing and methods2
  • Validation and qualification1
  • Regulatory submissions1

Regulatory intelligence

The rules behind this role

Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

Smith+Nephew on Regulatory Jobs

11
Open roles
10
Distinct roles
7
Locations

By discipline

  • Quality7 64%
  • Regulatory4 36%

By level

  • Senior & Principal5 45%
  • Associate & Specialist3 27%
  • Manager2 18%
See all 11 Smith+Nephew roles

More roles at Smith+Nephew

All 11 Smith+Nephew roles

Similar Quality Assurance roles elsewhere

Design Quality Engineer at Smith+Nephew

Applications close November 2. $74K–$112K a year, employer provided.

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