Lead Quality Auditor Job in Boston, Massachusetts US

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COMPANY INFO:

My Client is a global leader in the design and manufacture of injection molded plastic products  They are a trusted source in their industry, and have customers in many industries who rely on their expertise in technical services and products.  Their Boston area facility has identified the need for a LEAD QUALITY AUDITOR to perform internal Quality Systems Audits to evaluate and determine conformance to quality systems standards.. What a great opportunity for a  quality professional!!!

 

The LEAD QUALITY AUDITOR will:

·           Plan, schedule, coordinate and conduct Quality Systems audits.

·           Evaluate compliance of the audited organization and provide report of results to Auditee and Management

·           Participate with Auditee in the development of  committed corrective/preventive action plans

·           Verify implementation and effectiveness of agreed corrective/preventive actions

·           Analyze, report and trend audit observations

·           Track customer and third party audit findings through the Corrective Action/Preventive Action (CAPA) system to ensure timely closure.

·           Provide internal audit program direction, through training, mentoring, and coaching.

·           Review customer quality agreements and perform gap assessment against quality management system.

 

The  LEAD QUALITY AUDITOR will have:

·           BS degree in Engineering or  Life Science

·           5+  years of related QA experience in the Pharmaceutical or Medical Device industries, and at least 3 years of auditing experience  

·           Working knowledge of cGMP practices, Quality Systems (QSR 21 CFR 210, 211 and Part 820),

·            ISO 13485, Medical Device Directive, JPAL

·           Effective interpersonal and problem solving skills .  

·           ASQ Certified Quality Auditor

·           Boston area residency preferred

 

Qualified candidates please submit salary info and your resume as an MS Word attachment to jkroehler@mri-boston.com

 

Key words are: BS  Engineering or Life Science, Pharmaceuticals, Medical Device, cGMP,  ISO 13485, QSR  21 CFR 210, 211, Medical Device Directive, JPAL, Quality Systems,, ASQ Certified Quality Auditor, CAPA