Quality Engineering Manager

1 month ago


Mansfield, United States CareerBuilder Full time

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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