.SUMMARYThe Lead Quality Technician works under limited supervision, partnering with Manufacturing, Quality and Quality Engineering to continuously improve the quality performance and ensure compliance with quality standards. Performs measurement and validation tasks to support Production and Quality requirements. Trains department personnel in the proper use and interpretation of quality plans, and reviews and analyzes daily quality performance to identify, contain, control and improve quality.ESSENTIAL DUTIES AND RESPONSIBILITIESPerforms a variety of quality control test/inspections and complex analyses of raw materials, packaging materials and/or finished products from manufacturing to ensure quality standards and compliance to customer and regulatory requirements.Performs a variety of complex qualitative or quantitative tests on samples, and to aid in maintenance and certification of test instruments and apparatus to ensure compliance.Trains new inspectors regarding policies, procedures, inspection techniques. Monitors performance and institutes corrective action when necessary.Assures gauges are within the current calibration cycle and are properly used and stored. Arranges for repair of gauges.Participates in design of experiments and process capability studies.Reviews Statistical Process Control (SPC) data. Maintains integrity of SPC data by correcting input errors, maintaining control limits, and creating new files, and retraining as needed.Analyzes data and writes summaries to validate or show deviations from existing standards.Recommends modifications to existing, or suggests new standards, methods and procedures.Assists supervisor in prioritizing flow of work by coordinating the activities and daily work of employees of lower level quality maintenance and quality technicians based on productions schedules.Prepares graphs or charts of data or enters data into computer for analysis.Performs product and process audits.Participates in mold qualification/validation process.Conducts start-ups in accordance with inspection criteria.May inspect, measure, and test parts in accordance with blueprints, product plan requirements or engineering sketches.May plan, coordinate and perform layout inspection, process capability measurements and in-process inspection measurements.Responsible for recording bar code transaction using Worldwide Bar Code System.May oversee instrument calibration system, performs measurements and related calibration tasks.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