Quality Engineer
Intellectt INC
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.
Vacancy posted 1 day ago
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