Training and Document Control Specialist

Overview

Manage docs lifecycle, ensure regulatory compliance, support training, using PLM systems.

Key Responsibilities

• document control
• plm management
• change requests
• audit support
• user training
• regulatory compliance

Tasks

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. -Assist in the creation of project documentation books (Dossiers) and maintain accurate project records. -Maintain and control the creation, review, approval, distribution, and archival of quality and engineering documentation. -Support internal and external audits by ensuring documentation readiness and participating in audit processes. -Manage retention records and inactive files according to company policy and regulatory standards. -Process Change Requests (CRs), Engineering Change Orders (ECOs), and related documentation using electronic systems (PLM). -Support the implementation and maintenance of electronic documentation systems in PLM platforms (e.g., SAP, Arena, Master Control, Oracle). -Collaborate with cross-functional teams to ensure timely document updates and approvals for engineering and quality processes. -Ensure compliance with document control procedures and regulatory requirements such as ISO 13485, MDSAP, and GMP. -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.

Requirements

• plm
• microsoft office
• bilingual
• document control
• iso 13485
• 5+ years

What You Bring

-Experience with electronic document management systems in PLM such as Arena, SAP, Oracle, or Master Control. -Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and Learning Management Systems (LMS). -Bilingual (English/Spanish) must. -Strong understanding of document lifecycle management, change control, and quality documentation standards. -Expertise in Document Control systems and practices. -Proficient in Microsoft Office (Word, Excel, Outlook, PowerPoint). -Strong interpersonal and communication skills. -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. -Knowledge of ISO 13485, MDSAP, FDA or other regulatory frameworks (Desirable). -Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and learning management systems (LMS). -Bachelor’s degree in Engineering, Quality, Business Administration or related field (or equivalent experience).

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About Bepc Inc. - Business Excellence Professional Consulting

-Evolving from a technical consulting boutique, it expanded into IT project management and global talent services across borders. -Typical engagements include cleanroom commissioning, software and equipment validation, SAP deployment, and process automation. -Specializing in life sciences, high-tech manufacturing, automotive, IT systems, and construction sectors. -Operates a Mexico division catering to automotive and medical device clients, delivering engineering, validation, and automation services worldwide. -Known for seamless integration of Lean/Six Sigma methodologies with technical consulting to optimize client operations.

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