Document Control Specialist I

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 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. 

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.