Ensure compliance of components, assemblies and products to design requirements through physical, visual, and specialized testing. Document results in accordance with all pertinent procedural requirements. Create, validate and implement test processes to ensure component/product compliance. Support of quality related functions.
Perform receiving inspection functions on machine, molded and electrical components, utilize a wide variety of measurement tools (i.e. calipers, micrometers, CMM, Vision Systems, etc.) Perform in process and final inspections within area Value Streams as needed. Document results of inspections per company procedures.
Perform nonconformance analysis, evaluations, and disposition of NC's related to job function.
Interpret and implement various statistical tools including ANSI standard sampling plans, Process control charts, Capability analysis.
Create, update and implement procedures and work instructions in regard to inspections.
Utilize computer applications such as word processing, to develop spreadsheets and databases. Use these skills to document and analyze quality inspection data.
Utilize basic problem solving tools (fishbone diagrams, pareto analysis, etc.) to improve products and or processes.
Capable of reading and interpreting complex drawings, procedures and specification sheets.
High School Diploma or equivalent.
Associates degree in Technical Field or related
Knowledge of GMP's (Good Documentation Practices) Regulations,
Statistical training including trends, pareto and other basic charting techniques.
Five years of Quality Assurance / Control Experience
Quality Assurance experience in a Medical Manufacturing Environment