Quality Assurance Internal Audit Engineer/Specialist
Job Description
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.
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.
Responsibilities
- 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
Qualifications
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.
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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