Senior QA Engineer - Onsite

Ultimate Staffing Services; Portage (MI); In loco; USD 45.000 - 62.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

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

Mansioni

• 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)

Conoscenze

NC/CAPA experience

Print & document review

Med device or pharma

Formazione

Bachelor’s Degree in Engineering

Descrizione del lavoro

Senior QA Engineer - Onsite (JN -102026-433099) Portage, Michigan

Salary: USD39 - USD39 per hour

Start/End Dates: 10/26/2026 - 3/26/2027

Pay Rate: $39.00/hr.

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

Required Skills

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

EDUCATION:

• Bachelor’s Degree in Engineering (any discipline) required