Senior QA Engineer – Med Device, Post-Market Impact

Ultimate Staffing Services; Portage (MI); On-site; USD 45,000 - 62,000; Full time

Job summary

Ultimate Staffing Services is seeking a Senior QA Engineer for an onsite role in Portage, Michigan. This position focuses on quality across the product lifecycle and supports post-market insights to drive reliability improvements for healthcare products.

Responsibilities include investigating failures, trend analysis of post-market data, updating risk management documentation, and leading cross-functional CAPA activities to ensure regulatory and quality compliance.

Qualifications

• NC/CAPA experience, even better if TrackWise (1+ years)
• Print and document review experience (1+ years)
• Med device or pharma preferred

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.
• Good communication skills (2+ years)
• Documentation and print review (2+ years)
• Quality investigation experience (2+ years)

Skills

NC/CAPA experience

Print & document review

Med device or pharma

Education

Bachelor’s Degree in Engineering

Job description

Ultimate Staffing Services is seeking a Senior QA Engineer for an onsite role in Portage, Michigan. This position focuses on quality across the product lifecycle and supports post-market insights to drive reliability improvements for healthcare products.

Responsibilities include investigating failures, trend analysis of post-market data, updating risk management documentation, and leading cross-functional CAPA activities to ensure regulatory and quality compliance.