Document Control Specialist I

Cordis • Irvine, CA

7d • Onsite

About The Position

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Requirements

• Bachelor’s degree or equivalent education and experience; or an advanced degree with no previous professional experience.
• Experience working with document control and/or product lifecycle management systems.
• Strong attention to detail and commitment to accuracy.
• Proficiency in MS Office applications (Word, Excel, Outlook).
• Knowledge of ISO 13485, FDA 21 CFR Part 820, or similar quality system standards.
• Fluent in English

Nice To Haves

• 3+ years of document and change control experience in the regulated environment.
• 3+ years of relevant experience in the Medical Device Industry.
• Precise, rigorous, and detail-oriented approach to documentation.
• Strong communication and interpersonal skills, with the ability to collaborate across departments.
• Organized, self-motivated, and capable of handling multiple priorities.
• Supportive attitude and commitment to quality and compliance.
• Demonstrated integrity and accountability in document handling and record maintenance.

Responsibilities

• Manage document control and change control processes, ensuring proper document distribution and training assessment.
• Monitor change orders and associated training assignments to ensure timely completion of training in accordance with the change order implementation plan.
• Monitor and follow up on change order and periodic document review status to ensure Key Performance Indicator (KPI) goals are met.
• Provide training and support to PLM users on the change control process.
• Perform general filing and record keeping for controlled documents and quality records.
• Assist with document and data reviews as identified on quality master plan to ensure completeness and accuracy.
• Review and maintain documentation logs and indexes on a regular basis to ensure data integrity.
• Provide support for audit preparation and participate in document retrieval during audits.
• Support onboarding processes related to training and document access.
• Assist in continuous improvement initiatives, including CAPA and procedure updates.
• Perform other quality-related duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level