Quality Assurance Specialist

Job Description Summary

In the framework of Group policies and ISO 9001 Quality standards, provide support in order to implement, maintain, and eliminate waste, using continuous improvement methods and philosophy, in order to support operations, logistics and sales.

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 training.
• Meet or exceed all company safety procedures and standards with the understanding that all injuries are preventable through appropriate risk reduction.

Required Qualifications:

• Bachelor’s degree in Science or Engineering
• 2-4 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)

Preferred Qualifications:

• 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