Experienced Quality Engineer – Risk Management Specialist

Experienced Quality Engineer – Risk Management Specialist

Pay Rate: $44.78 per hour

Schedule:

Monday‑Friday Days
Assignment Length:
Anticipated Through 2026

This position pays up to $44 per hour and is expected to last through the end of the year, providing a strong opportunity to gain hands‑on experience in a highly collaborative, compliance‑driven environment. This is a high‑impact quality engineering role focused on product risk management across the full product lifecycle, ideal for someone passionate about compliance, continuous improvement, and cross‑functional collaboration in medical device or similarly regulated industries.

• Lead and support product risk management activities, including hazard analysis and risk assessments in alignment with ISO 14971
• Evaluate risks tied to complaints, manufacturing non‑conformances, and new product development
• Collaborate cross‑functionally with Engineering, Manufacturing, Regulatory, and Quality teams to ensure compliance
• Develop and maintain accurate, audit‑ready risk management documentation in accordance with FDA regulations and ISO standards
• Support complaint investigations, non‑conformance evaluations, and health hazard assessments
• Contribute to continuous improvement of risk management processes and quality systems
• Ensure compliance with GMP environments and participate in quality system audits

• Bachelor’s degree in Engineering or related technical field
• Minimum 3 years of quality engineering experience in a regulated environment (medical device, pharmaceutical, or similar)
• Hands‑on experience with risk management, complaint handling, and regulatory standards (FDA, ISO, GMP)
• Certified Quality Engineer (CQE) or equivalent preferred
• Strong analytical, problem‑solving, and documentation skills
• Experience with new product development and design assurance activities preferred
• Proven ability to collaborate effectively across technical and regulatory teams

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