Descripción del Trabajo
· 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
· 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
· 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.