Quality Engineer

Job Description

Works closely with development/manufacturing/quality engineering to establish and ensure compliance and quality for product related risk management documentation.

Ensure risk management assessments and evaluations for products conform to established standards and agency regulations.

This role will support product risk management activities across the product lifecycle, including evaluating risks associated with complaints, manufacturing non-conformances, and new product development.

Work cross-functionally with Engineering, Manufacturing, Regulatory, and Quality teams to establish and maintain compliant risk management documentation in alignment with FDA regulations and ISO standards.

Responsibilities include performing hazard and risk assessments, contributing to continuous improvement of risk management processes, and ensuring product risk documentation is accurate, complete, and audit-ready.

Required Qualifications

• Bachelor’s degree in Engineering or related technical field
• Minimum 3 years of experience in quality engineering within a regulated environment (medical device, pharmaceutical, or similar)
• Hands-on experience with product risk management, including hazard analysis and risk assessments (ISO 14971)
• Experience supporting complaint investigations, non-conformance evaluations, or health hazard assessments

Pay

Hourly Rate on W2: $42-$45/hr (depending on experience)

Schedule

Duration: 5.5 months (Possible extension/conversion based on performance and budget)