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