Sr. Quality Engineer
Company: Oxenham Group LLC
Posted on: January 27, 2023
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.
- 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
- 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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