Director, Quality Assurance

Accuray Incorporated; Deming (NM); On-site; USD 110,000 - 160,000; Full time

Job summary

Accuray in the United States is seeking a leader to oversee Manufacturing Quality Assurance and Supplier Quality across U.S. and international sites, including regulatory interactions.

You will shape quality strategy, manage a high-performing team, and ensure product release and compliance with global standards. The role partners with Manufacturing and Engineering to identify quality risks, drive continuous improvement, and prepare for regulatory inspections.

Qualifications

• Lead Manufacturing Quality Assurance and Supplier Quality across U.S. and international sites.
• Oversee operations, workforce planning, coaching, and performance management.
• Ensure compliance with FDA QMSR, ISO 13485, MDR and global regs.

Responsibilities

• Own and improve manufacturing quality system processes and product release.
• Provide QA oversight of manufacturing operations and process validation.
• Oversee supplier quality, audits, and external partnerships.
• Drive corrective actions, CAPA, and KPI monitoring.
• Lead regulatory readiness and host inspections.
• Foster culture of quality and cross-functional collaboration.
• Champion continuous improvement and operational excellence.

Job description

Give hope. Give health. Make your mark in the fight against cancer. At Accuray, we make a direct and powerful impact on the lives of cancer patients every day — helping them live longer, better lives. But our commitment to innovation offers a truly unique opportunity: the chance to change the fight against cancer — helping to develop, introduce and support new treatment delivery systems and software that will give new hope and new health to cancer patients and cancer survivors around the world. Accuray develops, manufactures and sells radiotherapy systems for alternative cancer treatments. Our radiation therapy for cancer makes treatment shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives.

Job Description

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.

EEO Statement

At Accuray, our commitment to patient-first outcomes drives an inclusive and collaborative work environment where the best ideas rise to the top — and everyone works to push them further. We value diversity in both the professional and personal backgrounds of our employees, as this variety adds rich energy to every team, every project and every work day. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin – including individuals with disabilities and veterans.

Our Vision and Mission

We work passionately to expand the curative power of radiation therapy to improve as many lives as possible. We pursue this by thinking, acting, and executing beyond expectations every day to deliver better, safer radiation therapy solutions and help patients get back to living their lives, faster.

Powerful Innovation that Delivers

We are committed to designing radiotherapy solutions that can take on the most complex challenges — while making commonly treatable cases even easier. From robotic to helical radiation therapy delivery, we invent unique, market-changing solutions that can meet the full spectrum of patient needs.