Quality Engineer - Medical Device - Westerly, RI

As a Quality Engineer, you'll partner cross‑functionally with engineering, manufacturing, and operations to ensure product and process excellence in a regulated environment. You'll drive continuous improvement, lead validation and CAPA activities, and play a hands‑on role in maintaining world‑class quality standards.

Client Details

Our client is a global manufacturing partner supporting cutting‑edge medical technology used in critical healthcare applications. They combine advanced cleanroom facilities with a strong quality culture and a commitment to innovation, safety, and continuous improvement.

Description

• Drive product and process quality using data‑driven, industry‑standard problem‑solving tools
• Lead MRB activities, manage NCRs, and oversee corrective and preventive actions to completion
• Own process and software validation activities, including PFMEA, IQ/OQ/PQ, PPAP, and FAIR
• Analyze manufacturing and validation data to reduce variation, defects, and waste
• Manage internal and customer change controls, ensuring alignment to specifications
• Partner with operations and ERP teams on routing and BOM approvals
• Support customer complaints through structured root‑cause analysis
• Participate in internal, customer, and regulatory audits
• Maintain a strong presence on the manufacturing floor to support quality excellence

Profile

• 1-3 years of experience in a medical device manufacturing environment
• Strong knowledge of ISO 13485 and FDA CFR Part 820 requirements
• Hands‑on experience with CAPA, validations, and statistical analysis (Minitab preferred)
• Excellent written, verbal, and cross‑functional communication skills
• Experience working in fast‑paced, regulated manufacturing settings

Job Offer

• Work on mission‑critical medical products that improve patient outcomes
• Gain exposure to full lifecycle quality engineering and validation work
• Collaborate with experienced engineering and operations teams
• Access advanced cleanroom manufacturing environments
• Join a company that values quality, safety, and continuous improvement

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.