Sr. Quality Engineer

Company: Oxenham Group LLC
Location: Burlington
Posted on: January 27, 2023

Job Description:

Job Title: Sr. Quality Engineer

Job Description: Our client is a Medical Device Company specializing in Vascular devices. The company is looking for a Sr. Quality Engineer. The position will be the subject matter expert for Corrective and Preventative Actions (CAPAs) sitewide.

Job Duties:

Manage the CAPA program including:
Assigning new CAPAs,
Following up on open CAPAs
Completing effectiveness checks on completed CAPAs
Author and improve QMS SOPs
Update QMS based on new quality standards, improving QMS processes as needed using Master Control QMS software
Support internal and external audits from regulatory agencies updating the QMS as needed based on findings

Requirements:
- Bachelors Degree (STEM preference)
- 7 years in an ISO 13485 environment

Keywords: Oxenham Group LLC, Boston , Sr. Quality Engineer, Engineering , Burlington, Massachusetts

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