Quality Coordinator - (Fraser, MI)

Rate of Pay $15 per hour 1. PRIMARY PURPOSE: Coordinator of all quality throughout the company. 2. ORGANIZATIONAL RELATIONSHIP: Reports to the Quality Manager 3. RESPONSIBILITIES: ? Understand basics of QMS and ISO9001:2008, Medical Device and FDA ? Maintain Document Control for the QMS ? Maintain the Record Retention Log ? Assist with maintaining the Operations Manual and Procedures ? Calibrate equipment and manage current revisions of templates ? Customer Complaints and Corrective/Preventive Action Reports ? Control of any non-conforming material, (quarantine, and investigate, CAPA) ? Create and maintain Device History Records [DHR] ? Create and maintain Article History Records [AHR] ? Create and maintain Work Instructions ? Perform QC Inspections of product ? Create/Submit (BOM’s) Bill of Materials to Purchasing ? Periodically inspect product throughout the warehouse ? Proformance Products batch sampling ? All other duties as deemed necessar