Quality Engineer - Medical Device - Westerly, RI

Job Title

Make a real impact on life-saving medical technologies

Own quality from validation to customer satisfaction

About Our Client

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.

Job 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

The Successful Applicant

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

What's on 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