Provides specialized engineering solutions & IT project management for Fortune 500 life science and tech firms.
Manage retention records and inactive files according to company policy and regulatory standards.
Provide document distribution to internal stakeholders and external clients, ensuring confidentiality and accuracy.
Support the implementation and maintenance of electronic documentation systems in PLM platforms (e.g., SAP, Arena, Master Control, Oracle).
Assist in the creation of project documentation books (Dossiers) and maintain accurate project records.
The Training and Document Control Specialist is responsible for the accurate management of documentation throughout its life cycle, ensuring compliance with internal quality procedures and external regulatory standards. This role provides dedicated support to the Training department, assisting intercultural teams across North America, and ensures documentation is properly processed, distributed, and archived across projects and operations.
Collaborate with cross-functional teams to ensure timely document updates and approvals for engineering and quality processes.
Provide user training and guidance on documentation best practices (GDP) and system usage.
Maintain and control the creation, review, approval, distribution, and archival of quality and engineering documentation.
Ensure compliance with document control procedures and regulatory requirements such as ISO 13485, MDSAP, and GMP.
Process Change Requests (CRs), Engineering Change Orders (ECOs), and related documentation using electronic systems (PLM).
Support internal and external audits by ensuring documentation readiness and participating in audit processes.
Bachelor’s degree in Engineering, Quality, Business Administration or related field (or equivalent experience).
Strong interpersonal and communication skills.
Experience with electronic document management systems in PLM such as Arena, SAP, Oracle, or Master Control.
Bilingual (English/Spanish) must.
Detail-oriented with excellent organizational and time-management skills.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and learning management systems (LMS).
Expertise in Document Control systems and practices.
Strong understanding of document lifecycle management, change control, and quality documentation standards.
Knowledge of ISO 13485, MDSAP, FDA or other regulatory frameworks (Desirable).
Proficient in Microsoft Office (Word, Excel, Outlook, PowerPoint).
5+ years of experience in document control, preferably in regulated industries such as medical devices, manufacturing, or engineering.