Quality Engineer

Quality Engineer

Genesis10 is currently seeking a Quality Engineer for a contract position with a Global Medical Technology Company located in Portage, MI. This is a 5+ month contract opportunity.

As a Quality Engineer, you will play a critical role in strengthening product reliability across the lifecycle, from post-market insights to product improvements that shape future innovations. This role offers meaningful impact, cross-functional collaboration, and the opportunity to influence products used by healthcare professionals worldwide.

Responsibilities:

• Investigate product failures by reviewing design history, manufacturing records, and field performance data to identify root causes and improvement opportunities
• Analyze and trend post-market product complaint data, delivering regular, data-driven insights to divisional quality leadership
• Update risk management documentation to reflect post-market findings and product changes, ensuring continued product safety and effectiveness
• Participate in cross-functional product improvement teams to define, prioritize, and execute corrective and preventive actions
• Initiate, track, and document commercial product holds, ensuring timely resolution and accurate records
• Support business units and commercial teams by providing post-market quality expertise and technical guidance
• Facilitate and coordinate subject matter experts to develop technical documentation for product field action assessments and present findings to governance boards and senior leadership
• Guide research and development teams through quality system requirements to ensure product changes comply with regulatory and quality standards, including reviewing change documentation for technical robustness

Requirements:

• Bachelor's Degree in Engineering (any discipline) required
• 2+ years of good communication skills
• 2+ years of documentation and print review experience
• 2+ years of quality investigation experience

Desired skills:

• 1+ years of NC/CAPA experience, preferably in TrackWise
• 1+ years of print and document review experience
• Experience with data trending
• Experience in the medical device or pharmaceutical industry is preferred

Pay range: $29.90 - $39.90 per hour

Only candidates available and ready to work directly as Genesis10 employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, please apply!