Quality Assurance Engineer

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 43 week of 2026