Manager, Manufacturing Quality Assurance

Accuray•Madison, WI

About The Position

At Accuray, we make a direct and powerful impact on the lives of cancer patients every day — helping them live longer, better lives. 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.

Requirements

Ability to furnish proof that they are authorized to work in the country they are applying on a permanent basis without sponsorship.

Responsibilities

Build, lead, and develop a high-performing, flexible Manufacturing Quality and Incoming Inspection team.
Set clear expectations, coach and develop team members, and drive accountability for performance and results.
Establish individual and team goals aligned with functional, cross-functional, and corporate objectives.
Foster a culture of quality, continuous improvement, and operational excellence.
Ensure effective quality oversight of manufacturing processes, including incoming inspection, in-process controls, and final product release.
Establish, maintain, and continuously improve inspection plans, sampling strategies, and acceptance criteria.
Ensure timely and compliant disposition of nonconforming materials, including rework and concession approvals.
Partner with R&D and Engineering to review new product designs and design changes intended for the Madison manufacturing campus.
Ensure robust design transfer into production, including appropriate process controls, documentation, and training.
Drive early identification and mitigation of manufacturing and quality risks.
Oversee validation activities for facilities, equipment, and manufacturing processes, ensuring compliance with regulatory requirements and internal standards.
Ensure validated state is maintained through appropriate change control and revalidation processes.
Leverage statistical techniques to monitor process capability and product quality performance.
Lead structured root cause investigations for defects, nonconformances, and quality events.
Ensure timely implementation of effective corrective and preventive actions (CAPA).
Drive continuous improvement initiatives that improve product quality, yield, and operational efficiency.
Establish and maintain compliant procedures, work instructions, and job aids in alignment with global quality system requirements.
Ensure adherence to ISO 13485, 21 CFR Part 820, MDSAP, and other applicable regulatory standards.
Support internal and external audits and regulatory inspections, ensuring audit readiness at all times.
Oversee calibration programs for tools and measuring equipment across the Madison campus and applicable global locations.
Ensure measurement systems are accurate, reliable, and compliant with regulatory requirements.
Champion the transition to digital quality records and paperless quality management system processes.
Drive effective utilization and continuous improvement of ERP and quality systems (e.g., SAP, MasterControl).
Collaborate closely with Manufacturing, Supply Chain, Supplier Quality, and Engineering teams to drive quality at the source.
Partner with suppliers and internal stakeholders to ensure incoming material quality and supplier performance.