Job Description
ESSENTIAL DUTIES AND RESPONSIBILITIES:
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.
Manufacturing Quality Oversight
- Ensure 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.
- Ensure timely and compliant disposition of nonconforming materials, including rework and concession approvals.
New Product Introduction & Design Transfer
- 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.
- Drive early identification and mitigation of manufacturing and quality risks.
Validation & Process Control
- 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.
Nonconformance, CAPA & Continuous Improvement
- 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.
Quality Systems & Compliance
- Establish and maintain compliant procedures, work instructions, and job aids in alignment with global quality system requirements.
- Ensure 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.
Calibration & Measurement Systems
- 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.
Digital Transformation & Systems
- 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).
Cross-Functional Partnership
- 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.
To qualify for this position, candidates must be able to furnish proof that they are authorized to work in the country they are applying on a permanent basis without sponsorship.
