Manager, Manufacturing Quality Assurance

Job Summary

Required Qualifications

• •Proof that they are authorized to work in the country they are applying on a permanent basis without sponsorship
• •Team Leadership & Talent Development
• •Build, lead, and develop a high-performing, flexible Manufacturing Quality and Incoming Inspection team
• •Set clear expectations, coach and develop team members, and drive accountability for performance and results
• •Establish individual and team goals aligned with functional, cross-functional, and corporate objectives
• •Foster a culture of quality, continuous improvement, and operational excellence
• •Effective quality oversight of manufacturing processes, including incoming inspection, in-process controls, and final product release
• •Establish, maintain, and continuously improve inspection plans, sampling strategies, and acceptance criteria
• •Timely and compliant disposition of nonconforming materials, including rework and concession approvals
• •Partner with R&D and Engineering to review new product designs and design changes intended for the Madison manufacturing campus
• •Ensure robust design transfer into production, including appropriate process controls, documentation, and training
• •Early identification and mitigation of manufacturing and quality risks
• •Oversee validation activities for facilities, equipment, and manufacturing processes, ensuring compliance with regulatory requirements and internal standards
• •Ensure validated state is maintained through appropriate change control and revalidation processes
• •Leverage statistical techniques to monitor process capability and product quality performance
• •Lead structured root cause investigations for defects, nonconformances, and quality events
• •Ensure timely implementation of effective corrective and preventive actions (CAPA)
• •Drive continuous improvement initiatives that improve product quality, yield, and operational efficiency
• •Establish and maintain compliant procedures, work instructions, and job aids in alignment with global quality system requirements
• •Adherence to ISO 13485, 21 CFR Part 820, MDSAP, and other applicable regulatory standards
• •Support internal and external audits and regulatory inspections, ensuring audit readiness at all times
• •Oversee calibration programs for tools and measuring equipment across the Madison campus and applicable global locations
• •Ensure measurement systems are accurate, reliable, and compliant with regulatory requirements
• •Champion the transition to digital quality records and paperless quality management system processes
• •Drive effective utilization and continuous improvement of ERP and quality systems (e.g., SAP, MasterControl)
• •Collaborate closely with Manufacturing, Supply Chain, Supplier Quality, and Engineering teams to drive quality at the source
• •Partner with suppliers and internal stakeholders to ensure incoming material quality and supplier performance