Leadership & Organizational Management

• Provide leadership and oversight of Manufacturing Quality Assurance and Supplier Quality functions across U.S. and international sites, including Chengdu.
• Establish organizational goals, priorities, and performance expectations aligned to business and quality objectives.
• Lead, develop, and manage a high-performing team, including workforce planning, coaching, and performance management.
• Oversee day-to-day operations, resource planning, and execution of departmental deliverables.

Quality Systems & Compliance

• Own and ensure effective implementation of manufacturing quality system processes, including production and process controls, product identification, traceability, nonconforming product control, and product release.
• Lead the development, maintenance, and continuous improvement of quality policies, procedures, and records to ensure compliance with applicable global regulations (e.g., FDA QMSR, ISO 13485, MDR).
• Ensure alignment and integration of manufacturing quality processes with enterprise Quality Management System (QMS) requirements.
• Promote awareness and understanding of regulatory requirements and customer expectations across the organization.

Operational Quality Oversight

• Provide QA oversight of manufacturing operations to ensure product conformity, process validation, and adherence to established quality standards.
• Partner with Manufacturing and Engineering to proactively identify and mitigate quality risks and drive robust production controls.
• Ensure effective execution of product release and manufacturing records review processes.

Supplier & External Quality

• Oversee quality assurance processes related to suppliers, distributors, and external partners, ensuring compliance with company and regulatory requirements.
• Ensure robust supplier quality management practices, including monitoring performance, adherence to quality agreements, and continuous improvement initiatives.

Continuous Improvement & Quality Events

• Drive continuous improvement through the effective use of quality metrics, trend analysis, and performance monitoring.
• Lead and support investigations, nonconformance management, and CAPA activities to ensure timely and effective resolution of quality issues.
• Establish and monitor key performance indicators (KPIs) to measure quality system effectiveness.

Regulatory & Inspection Readiness

• Lead inspection readiness activities and serve as primary site contact/host for regulatory inspections (e.g., FDA, Notified Body, international agencies).
• Support global regulatory strategies by ensuring manufacturing quality processes enable successful product approvals and market access.
• Serve as primary interface for NRTL testing and inspection activities at the Madison site.

Culture & Engagement

• Foster a culture of quality, accountability, and continuous improvement aligned with the company’s Quality Policy.
• Champion operational excellence and cross-functional collaboration to drive business results.

CORE COMPETENCIES:

• Personal Excellence
  • Effective in communication, always demonstrates professionalism, and has an accurate picture of self
• Strengthening the Team
  • Demonstrates high performance standards and effectively collaborates with the team, demonstrates a sense of ownership over assigned deliverables, and shows a high degree of motivation toward achieving individual and team goals

• Drive for Results
  • Applies financial discipline and a good business sense, supports change, and makes high quality and timely decisions

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.