Senior Engineer, Quality Assurance Engineering

Dexian; Portage (MI); On-site; USD 80,000 - 105,000; Full time

Job summary

Dexian is seeking a Senior Engineer, Quality Assurance Engineering in Portage, MI on site, for a 6‑month assignment with possible extension. You will drive product reliability from post‑market insights to future improvements, collaborating with cross‑functional teams to implement CAPAs and manage risk documentation.

The role emphasizes root-cause investigations, trend analysis of complaints, and strong involvement with governance boards.

Qualifications

• Good communication skills with 2+ years of experience.
• Documentation and print review experience of 2+ years.
• Quality investigation experience with 2+ years.

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.

Skills

Good communication

Documentation review

Quality investigation

Education

Bachelor's Degree in Engineering

Job description

Title: Senior Engineer, Quality Assurance Engineering

Location: Portage MI (Onsite)

Duration: 06 Months with possible extensions

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)

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

EDUCATION:

Bachelors Degree in Engineering (any discipline) required

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals.To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.