Quality Engineer (QMS Focused)

Location: Mahwah, NJ (Hybrid – Tues/Wed/Thurs onsite)

We are working with a growing mid-sized medical device manufacturer that is looking to add a Quality Engineer to focus on QMS activities. The ideal candidate will be able to assist in CAPA and Complaint Handling.

Responsibilities

• Own and drive CAPA and Complaint Handling, including investigations and root cause analysis
• Support and maintain the Quality Management System (QMS) and continuous improvement activities
• Partner with suppliers and cross-functional teams to resolve quality issues
• Support audits, remediation efforts, and ongoing regulatory compliance

Qualifications

• Experience in medical device quality engineering, with exposure to CAPA and complaints
• Working knowledge of ISO 13485 and FDA-regulated quality systems
• Strong communication skills and a hands-on, team-first mindset
• Big-company quality experience and/or exposure to drug delivery or combination devices is a plus