Manufacturing Quality Specialist - Accuro : Job Details

Job Title: Manufacturing Quality Specialist

Job Location: Sturtevant, WI

Job Type: 6+ Months contract

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