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Quality Systems Coordinator


Requisition Number: P11736

Region: US
State: Wisconsin
City: New Richmond

Responsibilities

  • Ensure highly effective and efficient systems for internal audits, corrective actions, continuous improvement, and related business systems
  • Carry out duties of Management Representative for quality and environmental systems 
  • Ensure quality system and EMS are kept current with changing FDA/ISO requirements 
  • Coordinate document control activities related to procedures, work instructions form control, and quality and EMS records
  • Participate on the Continuous Improvement Board 
  • Co-represent Facility in the Quality Council with the Quality Manager 
  • Identify, recommend, and facilitate implementation of best in class continuous improvement techniques within the facility through the Continuous Improvement Board 
  • Provide input in annual fiscal year business planning efforts, including establishing key performance measures, means of data collection, and reporting
  • Assist with various reports and presentation information preparation 
  • Actively participate in corporate/cross-facility teams to develop and implement new and improved systems such as Best Practices and Quality Systems as need 
  • Some programs may have vision requirements
  • Other duties as assigned
  • Safety/Environmental:
  • -Where applicable, individual is pre-planning safety into work activities to improve performance
  • -Proactively identifies safety concerns
  • -Complies with Environmental Management System program SOP’s/WI, Policy & Program elements and encourages responsible use of resources
  • Actively participate in continual improvement/innovation, corrective action and internal/external customer satisfaction

 

Qualifications - Education & Experience

  • BS Degree in Engineering with emphasis on Quality or equivalent certification in ASQE; 

                                                   OR

  • Associate’s Degree and six (6) years of relevant experience
  • Minimum of two (2) years of experience with manufacturing quality systems

Qualifications - Skills & Competencies

  • Experience and working knowledge with major quality systems:  GMP, ISO 9001, ISO13485, and 21 CFR Part 210/211 
  • Experience and working knowledge of process/flow chart computer programs
  • Formal Auditor training
  • Ability to manage multiple projects
  • Excellent communication skills:  written, verbal, and presentation skills including design and use of visual aids

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