Quality Assurance Internal Audit Engineer/Specialist
Bedford, MA 01803 US
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Title: Sr Specialist, Quality Assurance-Internal Audit
Hiring Organization: Connexion Systems & Engineering
- Duration: Temp to Perm
- Pay rate: $80-110k
- Job Location: Bedford, MA
- Job# 15366
As Sr. Specialist, Quality Assurance, he/she will perform task that will uphold and improve the product quality of medical devices manufactured and meet regulatory requirement to stay in compliance.
- Executes day to day activities based on quality objectives (goals) complementary to corporate policies and goals of building high quality medical devices.
- Audits the QMS and coordinates with external agencies to complete internal audits
- Prepares and Leads External Audits (MDD, MDR, ISO13485, MDSAP, UKCA)
- Updates the quality system based on non-conformities found during internal and external audits
- Leads and implements compliance and process improvements in Manufacturing and Quality Systems
- Determines root cause and implements Internal Audit Findings and Corrective and Preventative Actions
- Completes a trace matrix for new standards affecting the QMS
- Analyzes and reports quality system metrics
Bachelor's degree (B.A.) from four-year College or university preferably in Science or Engineering; and a minimum of six of experience in the medical device industry.
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