Your Future in Document Management Starts Here

Document Management Specialist The role of the Document Management Specialist revolves around ensuring the smooth management and control of documentation throughout its entire lifecycle. The primary goal is to guarantee compliance with internal quality procedures and external regulatory standards. This involves dedicated support for the Training department, assisting teams across North America. It ensures documentation is properly processed, distributed, and archived across projects and operations. Key Responsibilities: 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. Support the implementation and maintenance of electronic documentation systems in PLM platforms. Collaborate with cross-functional teams to ensure timely document updates and approvals for engineering and quality processes. Support internal and external audits by ensuring documentation readiness and participating in audit processes. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and learning management systems (LMS). Provide user training and guidance on documentation best practices and system usage. Manage retention records and inactive files according to company policy and regulatory standards. Assist in the creation of project documentation books (Dossiers) and maintain accurate project records. Provide document distribution to internal stakeholders and external clients, ensuring confidentiality and accuracy. BASIC QUALIFICATIONS: A Bachelor's degree in Engineering, Quality, Business Administration or related field (or equivalent experience). At least 5 years of experience in document control, preferably in regulated industries such as medical devices, manufacturing, or engineering. Expertise in Document Control systems and practices. Strong understanding of document lifecycle management, change control, and quality documentation standards. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and learning management systems (LMS). Experience with electronic document management systems in PLM such as Arena, SAP, Oracle, or Master Control. Detail-oriented with excellent organizational and time-management skills. Strong interpersonal and communication skills. Bilingual (English/Spanish) must.

Creado: Jue, 01 de Ene de 1970