Job Description

Job Description

Position Summary: the major duties and responsibilities of this position:

Works 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.
Performs a variety of quality control tests/inspections on products, materials, components and parts at various stages of the production process to ensure compliance with quality and reliability standards, and to ensure effective inspection and testing procedures are implemented.  Analyzes data and writes summaries to validate or show deviations from existing standards.  Recommends modifications to existing, or suggests new standards, methods and procedures.

Key Responsibilities and End Results: Essential responsibilities include but are not limited to the following):

Working under general supervision, assures policies, procedures, inspection techniques and quality plans conform to established standards.
Performs moderately 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.
Performs a variety of moderately complex qualitative or quantitative tests on samples, and to aid in maintenance and certification of test instruments and apparatus to ensure compliance.
Monitors performance of inspectors and institutes corrective action when necessary.
Trains new inspectors regarding policies, procedures, inspection and gauge techniques, and quality plans.
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 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.
Prepares graphs or charts of data or enter data into computer for analysis.
Participates in mold qualification/validation process.
Performs product and process audits.
Reviews production records for conformance to 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 plan, coordinate and perform layout inspection, process capability measurements and in-process inspection measurements.
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.
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.
Supports all company safety and quality programs and initiatives.
Reviews Statistical Process Control (SPC) data in Predisys. Maintains integrity of SPC data by correcting input errors and follows up with retraining of inspectors if needed.  May view SPC reports.

Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.

  Job Specifications :  The minimum education and experience required to perform this job competently:

High School degree or GED certificate and 2-4 years of inspection experience in injection molding, metrology, machine shop operations or similar industry/environment.
Ability to read and write English and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to do advanced mathematical computations.
General knowledge of blue prints, measuring and test equipment, SPC software and measurement techniques, and quality calibration processes required.
General knowledge of process control charts, process capability studies and other statistical analysis applications.
General knowledge of SPC and Predisys.

Organization Linkages:  T itles of individuals and organizations with which this position has the most frequent and significant contact:

Quality Assurance Team
Quality Control Team
Manufacturing Team