New · posted Nov 1
Accuray · Medical Devices
Director, Quality Assurance
- Madison, WI
- On-site
- Full-time
- Director
The role
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.
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.
What you need
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.
Where you'll work
Madison, WIOn-siteOpen in Maps (opens in a new tab)
More jobs in Madison, WI
From the posting
About Accuray
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.
Equal opportunity, accessibility and legal noticesAccuray's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
Director roles in the US108 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $187,625 | $210,000 | $241,000 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 971 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Accuray's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk8
- Collaboration and leadership7
- GMP and compliance4
- Documentation and SOPs2
- Investigations and CAPA2
- Lab testing and methods1
- Validation and qualification1
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
Company hiring pulse
Accuray on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Quality3 100%
By level
- Director1 33%
- Senior & Principal1 33%
- Associate & Specialist1 33%
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Director, Quality Assurance at Accuray
Open until filled.