담당업무
Responsibilities: - Coordinate QA, QC, and manufacturing batch record information to disposition raw materials, work in process and/or finished goods. - Maintain an effective system for CoA generation for finished goods. This includes specification review and data analysis related to control limits and customer specifications for shipping limits. - Serve as a subject matter expert in one or more of the quality systems used within the business unit. - Communicate effectively with production, maintenance, warehouse, and other functions to enable process and/or product optimization, problem prevention, ensure analytical systems are performing optimally, and identify and apply best practices across multiple sites.
- Develops / reviews and revises metrics / measurements that monitor key plant quality control points to assure alignment among production capabilities, laboratory method capabilities, and customer needs. - Possess a high comfort level in leading and implementing organizational change for solutions of complex problems and identifies deviations from accepted practice. Resolve quality related issues through leadership within material review boards - Assist in compliance QMS and customer audits in addition to leading internal audits. - Write, revise and review work instructions, training tools, and forms. - Completes all assigned trainings. - Meet or exceed all company safety procedures and standards with the understanding that all injuries are preventable through appropriate risk reduction.
자격요건
- Bachelor’s degree in Science or Engineering - 2-5 years of experience in a Quality role supporting a manufacturing operation with compliance to ISO 9001 quality requirements - A thorough understanding of statistical analysis and quantitative problem solving tools and methods. - Demonstrated experience developing sophisticated measurement techniques for complex parts. - Outstanding customer relations skills while defining specifications and resolving quality issues. - Knowledge in Quality Assurance fundamentals including ISO standards, drawing specifications, and end user quality and ERP software system usage. - Excellent detail and writing skills when completing paperwork. - English skills (verbal and written)
우대사항
- Experience in setting up systems and statistical methodologies to evaluate control limit data, customer complaint information, and other metadata sources. - Depth of knowledge and experience in one or more quality software systems (ERP, LIMs, Doc Control, Statistical Analysis Software) - Certified ISO 9001 auditor
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