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 Documentation Technician 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 RESPONSABILITIES:
- 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.
- Previous experience in Windchill system
- 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:
- Highschool or Technical Degree
- Previous experience in document control, in a medical devices, manufacturing, or engineering.
- Expertise in Document Control systems and practices.
- Strong understanding of document lifecycle management, change control, and quality documentation standards.
- Experience with WINDCHILL System or ADAPTIV
- 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.
- Bilingual (English/Spanish) must.
- J&J's experience is an advantage
MXOPS
Tipo de puesto: Tiempo completo
Sueldo: $100.00 - $200.00 al mes
Beneficios:
- Seguro de gastos médicos
- Seguro de gastos médicos mayores
Pregunta(s) de postulación:
- Sabes el sistema WINDCHILL O ADAPTIV
Idioma:
- Ingles avanzado (C1 O C2 ) (Obligatorio)
Lugar de trabajo: Empleo presencial