Document Control Specialist III

Accuray; Madison (WI); On-site; USD 60,000 - 90,000; Full time

Job summary

Accuray is seeking a document-control specialist to administer the controlled-document lifecycle, review submissions, and ensure alignment with quality-system requirements. You will maintain metadata, revision history, and access in electronic systems, supporting audits and training activities in a regulated medical-device environment.

The role involves preparing and distributing records, ensuring data integrity, and collaborating with global teams to uphold Good Documentation Practices.

Qualifications

• Associate degree or equivalent combination of education and relevant experience.
• Two years of experience in document control, change control, records management, or a related regulated field.
• Familiarity with Good Documentation Practices and data-integrity principles.
• Experience with ISO 13485, FDA QMS requirements, EU MDR, MDSAP.
• Proficiency with Microsoft 365 apps (Word, Excel, Outlook, Teams).
• Ability to interpret procedures and maintain confidentiality across global teams.

Responsibilities

• Administers controlled-document lifecycle activities, including creation, review, approval, issuance, revision, and archival.
• Reviews submissions for completeness, accuracy, approvals, and training impact; ensures regulatory compliance.
• Maintains document metadata, revision history, access permissions, and audit trails in enterprise systems.
• Sets up and maintains users, roles, and access in MasterControl and related systems.
• Monitors queues, aging, and cycle times; follows up on overdue records.
• Develops and maintains documents, templates, and training materials; provides guidance to authors and reviewers.
• Supports Change Review Boards with agendas, minutes, and action items; records decisions.
• Coordinates translation of documents and maintains version control across languages.
• Participates in audits and regulatory inspections by providing traceability evidence.
• Supports system implementations, upgrades, and data cleanups affecting document control.

Skills

Document control

Change control

Quality systems

Good Documentation Practices

ISO 13485 familiarity

FDA QMS familiarity

Microsoft 365

Education

Associate degree or equivalent

Tools

MasterControl

Electronic document-management systems

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

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Administers controlled-document lifecycle activities, including creation, review, approval, issuance, revision, effective-date management, obsolescence, archival, retention, and retrieval.
• Independently reviews and processes document and change-control submissions, including applicable ECOs, CHG Packets, MCOs, DCRs, part-number requests, medical device files, and design and development records, for completeness, accuracy, required approvals, effective dates, training impact, and compliance with established procedures.
• Reviews controlled documents for alignment with approved templates, internal QMS requirements, and applicable regulatory and quality-system requirements; identifies and escalates potential conflicts or compliance concerns to the appropriate process owner or Quality representative.
• Maintains document metadata, revision history, access permissions, workflows, audit trails, and related records in electronic document-management, quality-management, training, and product-lifecycle systems.
• Performs initial setup and periodic maintenance of users, roles, and access in MasterControl and other applicable enterprise systems for employees, suppliers, and authorized third parties.
• Monitors document and change-control queues, aging, cycle times, and periodic-review status; follows up with record owners to resolve overdue, inaccurate, or incomplete records.
• Develops and maintains Document Control procedures, work instructions, templates, forms, job aids, and training materials, as assigned.
• Provides training and day-to-day guidance to document authors, reviewers, approvers, and system users on document-control processes, change submissions, electronic design and development file setup, and system use.
• Supports Change Review Boards by preparing and distributing agendas, recording decisions and action items, publishing minutes, and maintaining associated records.
• Coordinates translated-document activities with internal stakeholders and external vendors while maintaining version control, review and approval evidence, and linkage to the approved source document.
• Supports internal audits, external audits, and regulatory inspections by retrieving records, demonstrating document-control processes, and providing traceability evidence.
• Participates in system implementations, upgrades, validation activities, user acceptance testing, data cleanup, document migrations, audit remediation, and process-improvement initiatives affecting document and change control.
• Uses Microsoft 365 applications and electronic enterprise systems to prepare, review, track, analyze, and communicate controlled information for global business functions.
• Protects confidential and proprietary information and complies with applicable records-retention, electronic-record, electronic-signature, data-integrity, and information-security requirements.

REQUIRED QUALIFICATIONS :

• Required :
• Associate degree or an equivalent combination of education and relevant experience.
• At least two years of experience in document control, change control, records management, quality systems, or a related function in a regulated industry.
• Working knowledge of Good Documentation Practices, data-integrity principles, and controlled-document lifecycle requirements.
• Familiarity with ISO 13485, FDA Quality Management System requirements, EU MDR, MDSAP, and applicable electronic-record and electronic-signature requirements.
• Experience using electronic document-management, quality-management, training-management, or product-lifecycle management systems.
• Proficiency with Microsoft 365 applications, including Word, Excel, Outlook, and Teams.
• Ability to interpret and consistently apply procedures, work instructions, templates, and documentation standards.
• Demonstrated attention to detail, sound judgment, problem-solving ability, and capacity to manage multiple priorities and deadlines in a fast-paced environment.
• Effective written and verbal communication skills and the ability to work collaboratively with global and cross-functional teams while maintaining confidentiality.
• Experience in the medical-device, pharmaceutical, biotechnology, or other regulated life-scienc