Quality Technician III - QA Lead TB

Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.

Key Responsibilities :

• 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 with customer and regulatory requirements.
• Monitors performance of inspectors and institutes 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 the repair of gauges as needed.
• Participates in the design of experiments and process capability studies.
• Reviews Statistical Process Control (SPC) data. Maintains the 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. Creates 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 the instrument calibration system, performs measurements, and related calibration tasks.
• Audits, maintains, and generates 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.
• Maintains files for batch history records (BHR). Reviews BHR’s for completeness and accuracy. Fills out lot history closeout / Batch Release form.

Works and follows up as needed with shipping to complete necessary information on Certificates of Compliance / analysis for product shipments.

• Assists Quality Engineer in the use of statistical tools in the workcell.
• Assists Quality Engineer with Corrective and Preventive Actions.
• Ensures capability studies are performed on critical processes.
• Performs first article inspection, reviews visual aids, and makes updates to inspection visual aids.
• Performs defect analysis reporting.
• Performs line, process, and product audits.
• Assists Quality Engineering in APQP.

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