Quality Engineer
The Fountain Group
The Fountain Group is currently seeking a Quality Engineer for a prominent client of ours. This position is located in Scarborough, ME . Details for the position are as follows:
Title: Quality Engineer
Location: Scarborough, ME
Duration: 5.5 months (Possible extension/conversion based on performance and budget)
Hourly Rate on W2: $42-$45/hr (depending on experience)
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.
- 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
Vacancy posted 2 days ago
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