About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About the role

The Document Control Specialist II is responsible for supporting and executing document control activities within the Quality Management System (QMS) in a regulated medical industry environment. This role ensures that quality documentation is properly controlled, maintained, and compliant with applicable regulatory standards. The position works cross-functionally to facilitate timely document processing, change control coordination, and audit readiness, contributing to operational efficiency and regulatory compliance.

What you'll do

Document Control Support:
Support the implementation and maintenance of document control processes aligned with the Quality Management System (QMS) and departmental objectives.

Document Management System Administration:
Maintain and administer the document management system, ensuring proper control, distribution, access, and archival of quality documents.

Regulatory Compliance:
Ensure documentation complies with applicable regulatory requirements and industry standards (e.g., ISO 13485, GMP, FDA regulations). Participate in internal and external audits and support audit readiness activities.

Process Execution and Improvement:
Execute established document control processes and identify opportunities for improvement. Support the implementation of process enhancements under guidance.

Cross-Functional Collaboration:
Work closely with Quality Assurance, Operations, Regulatory Affairs, and other departments to ensure timely and accurate document processing and updates.

Change Control Coordination:
Coordinate and track document change control activities, ensuring proper documentation, review, approval, and communication of changes.

Training Support:
Provide guidance and basic training to employees on document control procedures and system usage as needed.

Reporting and Metrics:
Generate routine reports on document control metrics (e.g., document status, approval timelines, compliance tracking) and support performance monitoring activities.

What you will bring

• Bachelor’s Degree.
• 4 - 7 year of experience.
• Advanced computer skills including MS Office applications (Word/Excel/PowerPoint/Project/Visio)
• Familiar with electronic management documentation.
• Spanish: Native Speaker, English: Fluent speaking, writing and reading.

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future.  At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity. 

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