Document Control Specialist III

Accuray • Madison, WI

6d

About The Position

Accuray develops, manufactures, and sells radiotherapy systems for alternative cancer treatments. The Document Control Specialist III administers controlled-document and change-control processes in a regulated medical-device environment. The role maintains document records and system access, supports users and Change Review Boards, coordinates translated documents, and helps ensure controlled information meets company procedures and applicable quality and regulatory requirements. The position also supports audits, inspections, system changes, validation, data cleanup, migrations, remediation, and process improvements.

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.
• 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 furnish proof of authorization to work permanently 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 controlled-document lifecycle activities, including creation, review, approval, issuance, revision, effective-date management, obsolescence, archival, retention, and retrieval.
• Independently review and process document and change-control submissions for completeness, accuracy, approvals, effective dates, training impact, and procedural compliance.
• Review controlled documents for alignment with approved templates, internal QMS requirements, and applicable regulatory and quality-system requirements; escalate potential conflicts or compliance concerns.
• Maintain document metadata, revision history, access permissions, workflows, audit trails, and related records in electronic document-management, quality-management, training, and product-lifecycle systems.
• Set up and periodically maintain users, roles, and access in MasterControl and other applicable 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.
• Provide 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.
• 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, maintaining version control, review and approval evidence, and linkage to the approved source document.
• Support internal audits, external audits, and regulatory inspections by retrieving records, demonstrating document-control processes, and providing traceability evidence.
• Participate in system implementations, 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 for global business functions.
• 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