JCW Group ยท 3 days ago
Quality Engineer (QMS)
JCW Group is a growing mid-sized medical device manufacturer seeking a Quality Engineer focused on QMS activities. The role involves managing CAPA and complaint handling, supporting the Quality Management System, and ensuring regulatory compliance.
Human ResourcesRecruitingStaffing Agency
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
Qualification
Required
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
Preferred
Big-company quality experience and/or exposure to drug delivery or combination devices is a plus