Quality - Investigator - Quality Assurance - Westborough, United States - TalentBurst, an Inc 5000 company

Description

What you'll do

• Execute the triage, investigation, and closure of product quality complaints.

• Run trend reports and perform statistical analysis of trends to identify emerging issues across various product groups and provides analysis around failure mode signals.

• 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.

• 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.

• Writes and reviews technical reports and investigation/CAPA memos which are communicated to customers

Who you are

• Bachelor's degree required; additional training/education preferred through ASQ (or relevant society) and/or Master's level program

• Minimum 7 years relevant experience industry experience (e.g. GMP medical device, pharmaceutical) required

• Minimum 7 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.)

• Experience with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance

• Demonstrated understanding and application of 21CFR Regulations with respect to Customer Complaints