Director of Manufacturing Quality Assurance

Accuray; Madison (WI); Vor Ort; USD 140.000 - 210.000; Vollzeit

Zusammenfassung

Accuray in Madison, WI seeks a seasoned leader to oversee Manufacturing Quality Assurance and Supplier Quality across U.S. and international sites, driving quality systems and regulatory readiness.

You will lead a high‑performing team, advance CAPA programs, and partner with Manufacturing and Engineering to ensure product release quality and compliance with FDA QMSR, ISO 13485, and MDR. The role demands strong leadership, strategic planning, and a deep commitment to patient safety and quality

Qualifikationen

• Experience leading manufacturing quality systems (FDA QMSR, ISO 13485, MDR)
• Proven ability to lead QA teams and manage CAPA
• Experience with regulatory inspections and readiness

Aufgaben

• Provide leadership of Manufacturing Quality Assurance and Supplier Quality across U.S. and international sites.
• Oversee production controls, traceability, product release, and quality records.
• Drive continuous improvement through quality metrics, trend analysis, and CAPA activities.
• Lead inspection readiness activities and interface with regulators (FDA, Notified Bodies, international agencies).
• Champion cross-functional collaboration to drive business results and quality culture.

Kenntnisse

Quality leadership

Cross-functional collaboration

Regulatory knowledge

Jobbeschreibung

Accuray in Madison, WI seeks a seasoned leader to oversee Manufacturing Quality Assurance and Supplier Quality across U.S. and international sites, driving quality systems and regulatory readiness.

You will lead a high‑performing team, advance CAPA programs, and partner with Manufacturing and Engineering to ensure product release quality and compliance with FDA QMSR, ISO 13485, and MDR. The role demands strong leadership, strategic planning, and a deep commitment to patient safety and quality