Quality Specialist

Essential Functions:

1. Prepare fill and assembly specifications for new items and update specifications when needed in fill and assembly specifications system.

1. Analyze components & bulk materials in order to confirm correct with bill of material, artwork and actual materials received.

1. Partner effectively with Customer Project Management group, Sales and other departments as needed to effectively prepare accurate specifications.

1. Effectively use the Monarch (MRP) system for demand analysis, PO placement, updating specifications, BOM analysis and general problem solving.

1. Utilizes customer’s systems such as SAP and other portals for retrieving data and other functions related to Production Quality.

1. Work with customers for confirming information related to new items and attend new start-ups to ensure all requirements are met.

1. Conducts meetings to delineate and review new item specifications. Confirm functions with operations between departments and to establish responsibilities and procedures for attaining quality standards.

1. Confers with manufacturing/sales/management about quality assurance of new products designed and manufactured products on market to rectify problems.

1. Establishes standards for quality control.

1. Maintains knowledge of current government and industry quality standards including but not limited to FDA, ISO, global standards, etc.

1. Investigates nonconformances/concerns related to customer complaints, reworks and internal nonconformances as they relate to the fill and assembly processes defined.

1. Maintains records related to customers current procedures and requirements.

1. Other duties, as assigned.