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. Typical Daily Duties 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 Qualifications 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 Call/text QUAL ENG to 207-774-8258 Email: portland.me@manpower.com #J-18808-Ljbffr
Experienced Quality Engineer - Risk Management Specialist • Westbrook, ME, United States
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