Senior Quality Assurance Engineer, Med Devices (Onsite)

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

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.