Quality Assurance Specialist (Mid Level)

Shift: 1st shift

Job Summary:

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

Must Have:
4 skills needed, Pharma background, quality Management Systems, Technical Writing and complete management experience