Quality Engineering Manager
1 month ago
Position: Quality Engineering Manager
Location: Onsite in Mansfield, MA
Responsibilities:
Responsible for management of site Quality Engineering activities including:
Process and equipment validations
Test method validations
Deviations
Non-conformance and CAPA investigations
Product hold management
Design/manufacturing change support
Test method validations
pFMEAs
Equipment management
Management of key Quality Management System elements including:
Control of Nonconforming Product
Deviations
Qualifications:
Bachelor's degree in STEM
5-7 years of experience Managing Quality Engineers in the Medical Device Industry.
Working knowledge of QA Engineering related QMS elements including: Design Controls, Production and Process Controls (including Process Validation), Control of Nonconforming Product, Facilities/Environmental Controls, Labeling and Packaging Controls, Handling, Storage, Packaging and Distribution of Product, Inspection and Test, Test Method Validations.
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