Quality Assurance Engineer

Quality Assurance Engineer

Location:

Hybrid Onsite Tuesday through Thursday Duration: 5-month contract Pay rate: $35-40/hour

Position Overview We are seeking a Senior 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 Track Wise 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. Contract duration: 5 months. Interview Process Candidates can expect a panel interview lasting approximately 30 45 minutes, including technical questions related to quality investigations, documentation review, and relevant quality engineering experience.