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Quality Systems Team Lead

Requisition Number: POS6690

Region: US
State: Wisconsin
City: New Richmond


• 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 and on the leading edge of customer expectations in regard to ISO 13485:2106, 21 CFR Part 820, 21 CFR Part 210/211, 21 CFR Part 4 and 21 CFR Part 11
• Guide customers and 3rd parties during audits of the quality system
• 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
• Manage the quality systems team, coordinating the activities around our key quality processes (document control, nonconforming, CAPA)
• Lead quality system improvements, facilitating changes from all functional groups within the facility
• 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;
• 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:  ISO 13485:2106, 21 CFR Part 820, 21 CFR Part 210/211, 21 CFR Part 4 and 21 CFR Part 11
• 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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