Director, Quality Assurance

Accuray•Madison, WI

22h

About The Position

Accuray develops, manufactures, and sells radiotherapy systems for cancer treatment. The Director, Quality Assurance provides leadership and oversight of Manufacturing Quality Assurance and Supplier Quality functions across U.S. and international sites, including Chengdu. The role establishes organizational goals, priorities, and performance expectations, leads and develops the team, and oversees departmental operations, resource planning, and deliverables. The position owns the effective implementation and continuous improvement of manufacturing quality-system processes and ensures their alignment with enterprise QMS requirements and applicable global regulations, including FDA QMSR, ISO 13485, and MDR. It provides quality oversight of manufacturing operations, product conformity, process validation, production controls, product release, and manufacturing-record reviews. The Director also oversees supplier and external-partner quality, drives quality investigations and CAPA, monitors quality metrics and KPIs, and leads inspection readiness. The role serves as the primary site contact and host for regulatory inspections and the primary interface for NRTL testing and inspection activities at the Madison site. The Director fosters a culture of quality, accountability, operational excellence, continuous improvement, and cross-functional collaboration. Candidates must be able to furnish proof that they are authorized to work permanently in the country where they apply, without sponsorship.

Requirements

Must be able to furnish proof of authorization to work in the country of application on a permanent basis without sponsorship.
Demonstrates effective communication and professionalism, with an accurate picture of self.
Demonstrates high performance standards and effective collaboration with the team.
Shows ownership of assigned deliverables and motivation toward individual and team goals.
Applies financial discipline and good business sense, supports change, and makes high-quality, timely decisions.

Responsibilities

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 with 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.
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 development, maintenance, and continuous improvement of quality policies, procedures, and records to ensure compliance with applicable global regulations.
Align and integrate manufacturing quality processes with enterprise QMS requirements.
Promote awareness and understanding of regulatory requirements and customer expectations across the organization.
Provide QA oversight of manufacturing operations to ensure product conformity, process validation, and adherence to quality standards.
Partner with Manufacturing and Engineering to identify and mitigate quality risks and drive robust production controls.
Ensure effective execution of product release and manufacturing-record review processes.
Oversee quality assurance processes for suppliers, distributors, and external partners, ensuring compliance with company and regulatory requirements.
Ensure supplier quality management practices, including performance monitoring, adherence to quality agreements, and continuous improvement.
Drive continuous improvement using 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 KPIs to measure quality-system effectiveness.
Lead inspection-readiness activities and serve as primary site contact and host for regulatory inspections, including FDA, Notified Body, and international-agency inspections.
Support global regulatory strategies by ensuring manufacturing quality processes enable product approvals and market access.
Serve as primary interface for NRTL testing and inspection activities at the Madison site.
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.