Senior Manufacturing Quality Engineer

Smith & Nephew; Mansfield (MA); Hybrid; USD 97,000 - 145,000; Full time

Benefits offered by this job

401k Matching Program

Tuition Reimbursement

Flexible Personal Time Off

Health, Dental, Vision benefits

Job summary

Smith+Nephew in Mansfield, MA is seeking a Senior Manufacturing Quality Engineer to lead CAPA and nonconformance activities in a regulated medical device environment.

You will collaborate with manufacturing and quality teams to strengthen processes, reduce defects, and ensure compliance with ISO 13485, FDA 21 CFR Part 820, and ISO 14971. Hybrid work options available with a strong focus on patient safety.

Qualifications

• Bachelor’s degree in Engineering such as Mechanical, Biomedical, Industrial, or a related discipline.
• 3–5 years of experience in quality engineering within a manufacturing environment.
• Experience in regulated industries and strong knowledge of quality systems and risk management.
• Familiarity with statistical analysis and PFMEA is desirable.

Responsibilities

• Lead nonconformance management and CAPA activities, including root-cause investigations and corrective actions.
• Partner with manufacturing and operations teams to improve process robustness and reduce variation and defect rates.
• Ensure compliance with 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 to evaluate and improve process capability.
• Support process validation activities including IQ, OQ, and PQ.

Skills

Quality engineering

CAPA leadership

Root cause analysis

Statistical analysis

Process improvement

Education

Bachelor's degree in Engineering

Job description

## Senior Manufacturing Quality EngineerApplylocations: Mansfield, MAtime type: Full timeposted on: Posted 30+ Days Agojob requisition id: R91347**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.