Medline Industries, Inc.
Northfield, MN
Job Summary Responsible for managing the quality and compliance for applicable products and processes for assigned area(s). Assume responsibility for a subset of individual projects that support the division and/or manufacturing area, compliance, new product development per the needs of the team. Job Description MAJOR RESPONSIBILITIES: Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO) pertaining to the applicable life cycle and regions of distribution for the product. Responsible for building and maintaining appropriate product documentation (e.g. Device Master Records, Design Controls, Risk Management, and CE Technical Files) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required. Acts as a liaison with the Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction. Help in complaint...