Document Control Specialist III

Accuray • Madison, WI

4d

About The Position

Accuray develops, manufactures, and sells radiotherapy systems for cancer treatment. The Document Control Specialist III administers controlled-document and change-control activities in a regulated environment, ensuring records are complete, accurate, properly approved, traceable, and managed in accordance with established procedures and applicable quality-system requirements. The role supports global business functions and works with document authors, reviewers, approvers, process owners, Quality representatives, suppliers, and external vendors.

The position manages document metadata, revision histories, workflows, access permissions, audit trails, and related records across electronic document-management, quality-management, training, and product-lifecycle systems. It also supports audits and regulatory inspections, Change Review Boards, translated-document processes, system changes and validation, data cleanup and migrations, training, and process-improvement initiatives. The specialist protects confidential and proprietary information and follows applicable records-retention, electronic-record, electronic-signature, data-integrity, and information-security requirements.

Candidates must be authorized to work permanently in the country where they apply without sponsorship.

Requirements

• 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 ability to collaborate with global and cross-functional teams while maintaining confidentiality.
• Experience in the medical-device, pharmaceutical, biotechnology, or other regulated life-sciences industry.
• Must be able to furnish proof of permanent authorization to work in the country of application without sponsorship.

Nice To Haves

• Bachelor’s degree in business administration, quality, information management, life sciences, engineering, or a related field.
• Experience with MasterControl, Agile, Oracle, SAP, or comparable electronic quality and product-lifecycle systems.
• Experience supporting audits or regulatory inspections.
• Experience with training administration, document migration, system validation, user acceptance testing, global document-control operations, or translated-document management.
• Relevant professional certification in records management, quality, regulatory affairs, or a related discipline.

Responsibilities

• Administer the controlled-document lifecycle, including creation, review, approval, issuance, revision, effective-date management, obsolescence, archival, retention, and retrieval.
• Independently review and process document and change-control submissions, including ECOs, CHG Packets, MCOs, DCRs, part-number requests, medical device files, and design and development records.
• Check submissions and controlled documents for completeness, accuracy, required approvals, effective dates, training impact, template alignment, and compliance with procedures and applicable quality-system requirements; escalate potential conflicts or compliance concerns.
• Maintain document metadata, revision history, access permissions, workflows, audit trails, and related records in applicable electronic systems.
• Set up and periodically maintain users, roles, and access in MasterControl and other enterprise systems for employees, suppliers, and authorized third parties.
• Monitor document and change-control queues, aging, cycle times, and periodic-review status; follow up with record owners on overdue, inaccurate, or incomplete records.
• Develop and maintain Document Control procedures, work instructions, templates, forms, job aids, and training materials, as assigned.
• Train and guide document authors, reviewers, approvers, and system users on document-control processes, change submissions, electronic design and development file setup, and system use.
• Support Change Review Boards by preparing and distributing agendas, recording decisions and action items, publishing minutes, and maintaining associated records.
• Coordinate translated-document activities with internal stakeholders and external vendors while maintaining version control, review and approval evidence, and linkage to approved source documents.
• Support internal audits, external audits, and regulatory inspections by retrieving records, demonstrating document-control processes, and providing traceability evidence.
• Participate in system implementations and upgrades, validation activities, user acceptance testing, data cleanup, document migrations, audit remediation, and process-improvement initiatives affecting document and change control.
• Use Microsoft 365 applications and electronic enterprise systems to prepare, review, track, analyze, and communicate controlled information.
• Protect confidential and proprietary information and comply with applicable records-retention, electronic-record, electronic-signature, data-integrity, and information-security requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree