With limited supervision, assures policies, procedures, inspection techniques and quality plans conform to established standards. • Performs complex analyses and tests of raw materials, packaging materials and/or finished products from manufacturing to ensure quality standards and compliance to customer and regulatory requirements. • Monitors performance of inspectors and institute corrective action when necessary. • Trains new inspectors and department personnel on policies, procedures, inspection techniques and quality plans. • Assures gauges are within the current calibration cycle and are properly used and stored. Arranges for repair of gauges as needed. • Participates in design of experiments and process capability studies. • Reviews Statistical Process Control (SPC) data. Maintains integrity of SPC data by correcting input errors and follows up with retraining of inspectors if needed. • Works with QA supervisor or manager to maintain and update control limits in SPC files. Create new SPC files as needed. • Participates in mold qualification/validation process • Reviews production records for conformance to procedures. • Analyzes data and writes summaries to validate or show deviations from existing standards. • Recommends modifications to existing, or suggests new standards, methods and procedures. • Conducts start-ups in accordance with inspection criteria. • Troubleshoots recurring defects and quality problems. Recommends disposition, modification and corrective actions for recurring or non-recurring discrepancies. • May inspect, measure, and test parts in accordance with blueprints, product plan requirements or engineering sketches. • May oversee instrument calibration system, performs measurements and related calibration tasks. • Audits, maintains and generate accurate quality records, logs and reports. • Ensures documentation and procedures are in compliance with customer specifications, industry standards and standard operating procedures. • Works with all QA and Manufacturing personnel to achieve regulatory compliance. • Maintain files for batch history records (BHR). Review BHR’s for completeness and accuracy. Fills out lot history closeout/Batch Release form. Work and follow up as needed with shipping to complete necessary information on Certificates of Compliance/analysis for product shipments. • Assist Quality Engineer in use of statistical tools in the workcell. • Assist Quality Engineer with Corrective and Preventive Actions • Ensure capability studies are performed on critical processes. • Perform first article inspection, review visual aids, and make updates to inspection visual aids. • Perform defect analysis reporting. • Perform line, process and product audits. • Assist Quality Engineering in APQP. • Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor
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