Document Control Specialist II
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. The Document Control Specialist II 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.
Requirements
- High school diploma is required/College degree preferred
- 3+ years of document and change control experience in the regulated regulate environment.
- 3+ years of relevant experience in the Medical Device Industry.
- 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
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
Number of Employees
1,001-5,000 employees
