Document Control Specialist I

Cordis; Irvine (CA); On-site; USD 59,400 - 73,700; Full time

Job summary

Cordis is seeking a Document Control Specialist I to support the Document Control function and ensure compliant handling of controlled documents and quality records.

You will collaborate with cross-functional teams, support PLM users, and contribute to training, audits, and continuous improvement initiatives in a regulated medical device environment.

Qualifications

• Bachelor’s degree or equivalent education or experience.
• Experience with document control and PLM systems.
• Strong attention to detail and accuracy.
• Proficiency in MS Office (Word, Excel, Outlook).
• Knowledge of ISO 13485, FDA 21 CFR Part 820 or similar quality standards.
• Fluent in English.

Responsibilities

• Manage document control and change control processes, ensuring proper distribution and training assessment.
• Monitor change orders and training assignments to complete training on schedule.
• Track change order and document review status to meet KPI goals.
• Provide training and support to PLM users on the change control process.
• Perform filing and record keeping for controlled documents and quality records.
• Assist with document/data reviews to ensure completeness and accuracy.
• Maintain documentation logs and indexes to ensure data integrity.
• Assist in audit preparation and document retrieval during audits.
• Support onboarding processes related to training and access to documents.
• Contribute to CAPA and procedure updates.

Skills

Attention to detail

MS Office proficiency

Fluent English

Quality systems knowledge

Education

Bachelor’s degree or equivalent education

Tools

Document Lifecycle Management (PLM) systems

Job description

Overview

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.

Overview

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.

Responsibilities

The Document Control Specialist I provides administrative and operational support to the Document Control function. This position works closely with cross-functional teams to ensure proper management, review, approval, and distribution of controlled documents and quality records; and provides support, coaching to new teammates, Product Lifecycle Management (PLM) system users on document control process and requirements. The role is essential to maintaining compliance with internal procedures, regulatory requirements, and audit readiness.

Key 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.

Qualifications

Required Qualifications

• 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

Preferred Qualifications:

• 3+ years of document and change control experience in the regulated environment.


• 3+ years of relevant experience in the Medical Device Industry.

Key Competencies

• 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.

Working Conditions

• Primarily office-based work environment.


• Requires occasional handling of documentation archives.


• Standard Monday–Friday schedule, with occasional overtime to meet project deadlines

Pay / Compensation

The expected pre-tax pay rate for this position is $59,400 – $73,700 per year . Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

Preferred Qualifications

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammates’ points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.