Senior Manufacturing Quality Assurance Engineer - Hybrid

Radiant Systems Inc; Portage (MI); Hybrid; USD 48,000 - 58,000; Full time

Job summary

Major Medical Device Client in Portage, Michigan is seeking a Senior Manufacturing Quality Assurance Engineer for a 5-month hybrid engagement. The role requires supporting change control approvals, NC/CAPA guidance, and QE tasks with 3 days on-site minimum.

Ideal candidates have 2+ years in quality investigations, documentation reviews, and strong communication skills. Bachelor’s degree in Engineering is required. This position is W2 with pay rate $35.00-$42.00 per hour.

Qualifications

• 2+ years of good communication skills
• 2+ years documentation and print review experience
• 2+ years quality investigation experience

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.

Skills

Communication skills

Documentation review

Quality investigation

Education

Bachelor’s Degree in Engineering

Tools

TrackWise

Job description

We are hiring Senior Manufacturing Quality Assurance Engineer - Hybrid.

Client: Major Medical Device Client

Position: Senior Manufacturing Quality Assurance Engineer - Hybrid

Duration: 5 months on W2

Location: Portage, Michigan 49002

Pay Rate: $35.00-$42.00/ Hr on W2

Job Description

Hybrid / 3 days onsite minimum

Looking for temp support in change control approvals, NC/CAPA guidance, and QE tasks.

• 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)


• Med device or pharma preferred

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.

EDUCATION:

Bachelor’s Degree in Engineering (any discipline) required