Mechanical, electrical and cosmetic inspection of medical device products and parts.
Perform final outgoing quality inspection on products prior to shipping.
Perform product line process audits to assure products are being built according to established manufacturing work instructions.
Interface and communicate with Engineering staff or production management concerning discrepancies found and/or reject issues.
Support Sr. Quality Engineer regarding data collection and quality reporting of product lines
Assist with Document Control functions to maintain the Quality Management System (QMS).
Perform Internal auditing of the QMS to ISO9001:2008 and ISO13485:2003 standards as a member of VMSI Internal audit team.
Help support Incoming Quality Control of Electrical/Mechanical parts when needed.
Be able to write Nonconformance Reports and Corrective Action Requests (CARS) on discrepant product/parts when needed.
Basic knowledge on Microsoft office (and SAP QM module a plus).
Able to interpret technical drawings , inspection checklists, procedures and sampling plans
Authority:
Able to recommend disposition for nonconforming Incoming Inspected parts at production.
Able to inspect and disposition medical products to established inspection checklists.
Please see JD