Title: Quality Engineer II (NPD/Sustaining) Duration: 3 months to start Location: Fully onsite in Devens, MA (hours are 8am-5pm with an hour lunch) Rate - $45-50/hr
Environment: Our client is a medical device manufacturer looking for a Quality Engineer II to provide support for a large project installation. They are specifically supporting the development of a combination product.
Duties/Responsibilities: Provide Quality Engineering and Validation support for the Program Managers on customer programs as required Automated production line validation Time out of refrigeration / time out of environment. Review daily rejects and implement or discuss action plans Manage and investigate customer complaints Manage CAPAs Make appropriate changes in documentation as required Make appropriate changes to fixtures or inspection methods Create/Maintain FMEA's, AQPs, Deviations, Process flows, Validation Plans, IQ/OQ/PQ protocol's, PPAP's as appropriate Manage, analyze, and create reports for Process Capability studies, FAIR's, GR&Rs, and other data before sending to customer Create, modify, and maintain History Cards/ Control Plans /Inspection Work Instructions Participate in internal and supplier audits Participate in design reviews
Required:
Medical Device/Combination Product Experience Quality Engineering New Product Development Sustainability IQ/OQ/PQ FMEAs
Numbers & Facts
Location
NULL, MA
Salary
$45–$50
Skills
Analysis Skillsunmatched
Failure Mode and Effects Analysis (FMEA)unmatched
Internal Auditunmatched
Medical Equipmentunmatched
Process Capabilityunmatched
Process Flowunmatched
Process Validationunmatched
Product Developmentunmatched
Production Part Approval Process (PPAP)unmatched
Quality Engineeringunmatched
Refrigerationunmatched
Reporting Skillsunmatched
Sustainabilityunmatched
Validation Planunmatched
Vendor/Supplier Evaluationunmatched
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