Manufacturing Quality Specialist Job at Accuro, Sturtevant, WI

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  • Accuro
  • Sturtevant, WI

Job Description

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

Job Tags

Contract work,

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