Quality Engineer - Contract

Comrise; Portage (MI); Hybrid; USD 47,000 - 63,000; Part time

Job summary

Comrise is seeking a Quality Assurance Engineer to support product quality, post-market investigations, and CAPA activities for regulated products. This role emphasizes quality investigations, documentation, and product improvement, with a hybrid on-site schedule (Tue–Thu). The contract runs for 5 months and requires collaboration across cross-functional teams.

The candidate will review documentation, support CAPAs, and help ensure regulatory compliance throughout the product lifecycle.

Qualifications

• Bachelor's degree in Engineering required.
• Experience in quality engineering, QA, or investigations.
• Strong communication and cross-functional collaboration.
• Experience reviewing technical documentation or controlled QC documents.
• Experience investigating product failures and customer complaints.
• Strong analytical and documentation skills with attention to detail.

Responsibilities

• Investigate product failures to identify root causes and improvements.
• Analyze post-market complaint data and communicate findings to quality leadership.
• Review NC records, CAPAs, and engineering change documentation.
• Guide NC/CAPA processes and ensure timely issue resolution.
• Review change control requests for compliance with quality systems.
• Update risk management documentation with post-market findings.
• Collaborate to implement corrective and preventive actions and product improvements.
• Coordinate with Recall Team on technical docs for field actions.
• Provide quality guidance to engineering, R&D, and commercial teams.
• Support quality activities and reviews to maintain compliance.

Skills

Communication skills

Root cause analysis

Documentation skills

Cross-functional collaboration

Attention to detail

Quality investigations

Education

Bachelor's degree in Engineering

Tools

TrackWise

Job description

Location: Hybrid - Onsite Tuesday through Thursday

Duration: 5-month contract

Position Overview

We are seeking a Quality Assurance Engineer to support product quality, post-market investigations, and quality system activities for products within a regulated industry. In this role, you will investigate product failures, identify root causes, review quality documentation, and support change control approvals and corrective and preventive actions (CAPAs).

You will collaborate with cross-functional teams, including product quality, engineering, and recall teams, to help ensure product reliability, regulatory compliance, and continuous improvement throughout the product lifecycle.

This position is focused on quality investigations, documentation, and product improvement—not day-to-day production support.

Key Responsibilities

• Investigate product failures by reviewing design history, manufacturing records, product complaints, and field performance data to identify root causes and opportunities for improvement.
• Analyze and trend post-market product complaint data and communicate findings and recommendations to quality leadership.
• Review and support quality documentation, including nonconformance (NC) records, CAPAs, and engineering change control documentation.
• Provide guidance on NC/CAPA processes and support timely resolution and accurate documentation of quality issues.
• Review change control requests and technical documentation to ensure product changes comply with established quality system requirements.
• Update risk management documentation to reflect post-market findings, product changes, and potential safety concerns.
• Collaborate with cross-functional teams to develop and implement corrective and preventive actions and product improvement strategies.
• Initiate, track, and document commercial product holds, ensuring appropriate follow-up and resolution.
• Work closely with the Recall Team and coordinate subject matter experts in developing technical documentation for product field action assessments.
• Provide quality expertise and technical guidance to engineering, research and development, and commercial teams.
• Support quality-related activities and documentation reviews to maintain product safety, reliability, and regulatory compliance.

Required Qualifications

• Bachelor's degree in Engineering in any discipline is required.
• Relevant experience in quality engineering, quality assurance, or quality investigations.
• Strong communication skills, including the ability to communicate technical findings and collaborate with cross-functional stakeholders.
• Experience reviewing technical documentation, engineering prints, or controlled quality documents.
• Experience investigating product failures, quality issues, or customer complaints.
• Ability to analyze information, identify root causes, and document findings clearly.
• Strong organizational skills and attention to detail.

Preferred Qualifications

• Experience in the medical device or pharmaceutical industry; candidates from other regulated industries may also be considered.
• Experience with nonconformance (NC) management and CAPA processes.
• Familiarity with TrackWise or similar quality management systems.
• Experience with change control reviews and approvals.
• Experience with product complaint data analysis, trending, and risk management documentation.
• Approximately 10 years of relevant experience may be considered, depending on the candidate's background and alignment with the position's budget.

Work Schedule and Contract Details

• Work arrangement: Hybrid, onsite Tuesday through Thursday (3 days per week).
• Training: Onsite attendance is required during the training period.
• Extension: No extension is currently planned. However, there may be opportunities to connect with other teams for potential future assignments.