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