Title: Quality Engineer Location: Devens, MA Work Arrangement: 100% Onsite Employment Type: Contract W2 Duration: 3 Months + Extension Potential Rate: $44 - $48/hr W2 Industry: Medical Devices
About the Role
Seeking a Quality Engineer II to provide Quality Engineering and Validation support for new product development, sustaining activities, and combination product projects.
Key Responsibilities
Support automated production line validation and IQ/OQ/PQ activities.
Manage CAPAs, customer complaints, deviations, and quality investigations.
Develop and maintain FMEAs, AQPs, process flows, validation plans, and control plans.
Support process capability studies, FAIRs, GR&Rs, and inspection documentation.
Participate in design reviews, internal audits, and supplier audits.
Requirements
Medical device and combination product experience.
Quality Engineering experience in NPD/sustaining environments.
Experience with IQ/OQ/PQ and FMEAs.
Strong data analysis, documentation, and problem-solving skills.
Numbers & Facts
Location
Devens, MA
Salary
$44–$48
Skills
Documentationunmatched
Engineeringunmatched
Internal Auditunmatched
Medical Equipmentunmatched
Process Capabilityunmatched
Process Flowunmatched
Process Validationunmatched
Product Developmentunmatched
Product Supportunmatched
Production Supportunmatched
Quality Engineeringunmatched
Sustainabilityunmatched
Validation Planunmatched
Vendor/Supplier Evaluationunmatched
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