Contract Manufacturing Organization Quality Specialist

Business Title: 3074 | Contract Manufacturing Organization Quality Specialist Location: Sturtevant, WI 53177 Job Type: Contract (6 M+) Job Responsibilities: Ensure quality in the day to day activities of the manufacturing organizations of electro-mechanical devices Ensure products meets established quality standards throughout the manufacturing process Provide direct support to Quality Management/Quality Engineering personnel regarding operation of the department and Quality System Perform a wide array of activities related to: Manufacturing Support, Change Control, Nonconformance Records (NCR), Corrective and Preventive Action (CAPA), Product Surveillance, New Markets and Risk Management Perform: monitoring and improving first pass yield, analyzing sources of and reducing scrap, analyzing sources of quality issues and prompt resolution Ensure the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated Skills & Experience Required: Bachelor's degree in relevant field 2+ years Medical Device or Pharmaceutical Industry or similar experience 2+ years In a Quality Role 2+ years Working with electromechanical device manufacturing or contract manufacturing 2+ years In Manufacturing Quality or Operations Role ASQ Certifications or equivalent preferred Experience in root cause analysis tools, CAPA, NCR, SCAR investigations Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations Familiarity with cGMP regulations and FDA/USP/EP/BP/ICH guidelines