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.
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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-sciences industry.
Preferred or Desired:
- 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 related discipline.
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.
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.