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Quality Assurance/Engineering

$72.8k - $83.2k
Full-time

Comrise

Salary: $72,800 - 83,200 per year Requirements:
Bachelors degree in engineering in any discipline
Relevant experience in quality engineering, quality assurance, or quality investigations
Strong communication skills, including the ability to explain 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 clearly document findings
Strong organizational skills and attention to detail
Preferred: Experience in medical devices, pharmaceuticals, or another regulated industry
Preferred: Experience with nonconformance management and CAPA processes
Preferred: Familiarity with TrackWise or a similar quality management system
Preferred: Experience with change control reviews and approvals
Preferred: Experience analyzing and trending product complaint data and maintaining risk management documentation
Approximately 10 years of relevant experience may be considered, depending on the candidates background and alignment with the roles budget
Responsibilities:
Investigate product failures by reviewing design history, manufacturing records, product complaints, and field performance data to identify root causes and improvement opportunities
Analyze and trend post-market product complaint data, and share findings and recommendations with quality leadership
Review and support quality documentation, including nonconformance records, CAPAs, and engineering change control documents
Guide nonconformance and CAPA processes, supporting timely resolution and accurate documentation of quality issues
Review change control requests and technical documentation to ensure product changes meet established quality system requirements
Update risk management documents to reflect post-market findings, product changes, and potential safety concerns
Work 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
Coordinate with the Recall Team and subject matter experts to develop technical documentation for product field action assessments
Provide quality expertise and technical guidance to engineering, research and development, and commercial teams
Support quality activities and documentation reviews to help maintain product safety, reliability, and regulatory compliance
Technologies:
~ Support

More:
We are seeking a Senior Quality Assurance Engineer to support product quality, post-market investigations, and quality system activities in a regulated industry. The role focuses on investigations, documentation, and product improvement rather than day-to-day production support, with collaboration across product quality, engineering, and recall teams. This is a five-month contract paying $35–$40 per hour, with a hybrid schedule requiring onsite work Tuesday through Thursday; onsite attendance is also required during training. The interview includes a panel discussion and technical questions about quality investigations, documentation review, and relevant quality engineering experience.
last updated 42 week of 2026

Vacancy posted 4 days ago
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