Divisional Quality Engineer

Divisional Quality Engineer 5-Month Contract Hybrid in Portage, MI Summary Our client has engaged GForce Life Sciences to provide a Senior Engineer in Quality Assurance Engineering. This contract role will support product reliability and post-market quality activities across the product lifecycle, contributing to innovations used by healthcare professionals worldwide. Responsibilities Investigate product failures by reviewing design history, manufacturing records, and field performance data to identify root causes and areas for improvement.Analyze and trend post-market product complaint data, providing regular data-driven insights to divisional quality leadership.Update risk management documentation to incorporate post-market findings and product modifications, ensuring ongoing safety and effectiveness.Participate in cross-functional teams to define, prioritize, and implement corrective and preventive actions.Initiate, track, and document commercial product holds, ensuring resolution and compliance documentation are maintained.Support business units and commercial teams with post-market quality expertise and technical guidance.Coordinate subject matter experts in developing technical documentation for field action assessments and presenting findings to governance boards and senior leadership.Guide research and development teams through quality system requirements, reviewing change documentation to ensure regulatory and quality standards are met. Mandatory Requirements Bachelor’s Degree in Engineering (any discipline).Minimum of 2 years experience in quality investigation, documentation review, and print review.Good communication skills, demonstrated over at least 2 years.Experience investigating product failures and analyzing post-market complaint data. Nice to Have Experience with NC/CAPA processes, especially within TrackWise (1+ years).Data trending expertise.Experience reviewing print and technical documentation.Background in medical device or pharma industries preferred.