Document Control Specialist

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 926.784 - 1.297.497; Jornada completa

Descripción de la vacante

A specialized consulting firm in Ciudad Juárez is seeking a Training and Document Control Specialist to manage documentation and ensure compliance with regulatory standards. The ideal candidate will have a Bachelor's degree and over 5 years of experience in document control, preferably in the medical devices industry. Strong organizational and communication skills are essential for collaborating with teams across North America and ensuring document accuracy and confidentiality.

Formación

• 5+ years of experience in document control, preferably in regulated industries.
• Strong understanding of document lifecycle management and change control.
• Knowledge of ISO 13485, MDSAP, FDA is desirable.

Responsabilidades

• Maintain and control documentation throughout its life cycle.
• Ensure compliance with document control procedures and regulatory requirements.
• Support internal and external audits by ensuring documentation readiness.

Conocimientos

Expertise in Document Control systems

Strong interpersonal and communication skills

Attention to detail

Proficient in Microsoft Office Suite

Educación

Bachelor’s degree in Engineering, Quality, Business Administration

Herramientas

PLM systems (Arena, SAP, Oracle, Master Control)

Descripción del empleo

Overview

BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.

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.

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 (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.
• 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 (GDP) 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

• Bachelor’s degree in Engineering, Quality, Business Administration or related field (or equivalent experience).
• 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.
• Proficient in Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Knowledge of ISO 13485, MDSAP, FDA or other regulatory frameworks (Desirable).
• Detail-oriented with excellent organizational and time-management skills.
• Strong interpersonal and communication skills.
• J&J's experience is an advantage