Senior Quality Assurance Engineer

Intepros; Portage (MI); On-site; USD 85,000 - 110,000; Full time

Job summary

Intepros is seeking a Divisional Quality Engineer to strengthen product reliability across the lifecycle, from post-market insights to future innovations used by healthcare professionals worldwide.

You will investigate failures, analyze post-market data, update risk management, and lead cross-functional teams to drive corrective actions and regulatory compliance.

Qualifications

• Bachelor's Degree in Engineering required.
• 2+ years in quality investigation and problem-solving.
• Experience with design history review and post-market data analysis.

Responsibilities

• Investigate product failures by reviewing design history, manufacturing records, and field performance data.
• Analyze and trend post-market product complaint data delivering data-driven insights.
• Update risk management documentation reflecting post-market findings and changes.
• Participate in cross-functional teams to define, prioritize, and execute CAPAs; track product holds.
• Coordinate experts to develop technical documentation for field action assessments and present findings to governance boards.
• Guide R&D teams through quality system requirements ensuring changes comply with regulatory standards.

Skills

Communication

Documentation review

Quality investigations

Education

Bachelor's Degree in Engineering

Job description

As a Divisional 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.

What You Will Do ~

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.

TOP 3 Skills

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

Top 3 Nice To Haves

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

EDUCATION: Bachelor s Degree in Engineering (any discipline) required

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