• 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. Comply and follow all procedures within the company security policy.
• May perform other duties and responsibilities as assigned.
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