Senior Quality Engineer, Medical Devices: CAPA & Process

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

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.