Divisional Quality Engineer - Post-Market Impact (Hybrid)

Actalent; Portage (MI); Hybrid; USD 44,000 - 63,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability coverage

Health Spending Account (HSA)

Transportation benefits

PTO / Vacation

Job summary

Actalent in Portage, MI is seeking a Divisional Quality Engineer to strengthen product reliability across the lifecycle. This hybrid role combines on-site collaboration Tue–Thu with remote work Mon and Fri, supporting post-market insights and design improvements for healthcare products worldwide.

You will lead cross-functional teams, perform root-cause analysis, update risk docs, and guide R&D through quality systems to ensure regulatory compliance. Contract position with competitive benefits.

Qualifications

• Quality engineering experience.
• Corrective and preventive action experience.
• Complaint investigation skills.
• Good communication skills (2+ years).
• Documentation and print review (2+ years).
• Quality investigation experience (2+ years).
• NC/CAPA experience, preferably in TrackWise (1+ years).
• Data trending 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, including reviewing change documentation for technical robustness.

Skills

Quality engineering

CAPA experience

Complaint investigation

Communication skills

Documentation review

Quality investigations

TrackWise

Data trending

Education

B.S. in engineering

Tools

TrackWise

Job description

Actalent in Portage, MI is seeking a Divisional Quality Engineer to strengthen product reliability across the lifecycle. This hybrid role combines on-site collaboration Tue–Thu with remote work Mon and Fri, supporting post-market insights and design improvements for healthcare products worldwide.

You will lead cross-functional teams, perform root-cause analysis, update risk docs, and guide R&D through quality systems to ensure regulatory compliance. Contract position with competitive benefits.