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.