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<strong>Quality - Investigator - Quality Assurance (Mid Level)</strong><br><br><strong>Westborough, MA</strong><br><br><strong>6 MONTHS</strong><br><br><strong>What you'll do</strong><br>• Execute the triage, investigation, and closure of product quality complaints.<br>• Run trend reports and perform statistical analysis of trends to identify emerging issues across various product groups and provides analysis around failure mode signals.<br>• Support in CHU complaint handling and QA product root cause investigations as deemed appropriate by management. Support with tracking major issues and related corrective actions.<br>• Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations; responsible for documentation of objective evidence in QMS records.<br>• Writes and reviews technical reports and investigation/CAPA memos which are communicated to customers<br><br><strong>Who you are</strong><br>• Bachelor's degree required; additional training/education preferred through ASQ (or relevant society) and/or Master's level program<br>• Minimum 7 years relevant experience industry experience (e.g. GMP medical device, pharmaceutical) required<br>• Minimum 7 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.)<br>• Experience with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance<br>• Demonstrated understanding and application of 21CFR Regulations with respect to Customer Complaints
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