Document Control Specialist (12-month contract)

Stryker; Tijuana; Presencial; MXN 300,000 - 400,000; Jornada completa

Descripción de la vacante

A leading medical device company in Tijuana is seeking a Document Control Coordinator. You will ensure the integrity of documentation processes, implement the Engineering Change Notice system, and support compliance with regulatory standards. Candidates should have a Bachelor's degree, 3+ years of experience in Document Control, and be bilingual in Spanish and English. This position requires a proactive approach to quality management and collaboration across teams.

Formación

• Minimum of 3 years of experience in Document Control.
• Knowledge of 21 CFR Part 820, ISO 13485, or equivalent medical device regulations.
• Availability to work under a 12-month contract.

Responsabilidades

• Coordinate document control and updates within the Quality System.
• Implement and maintain the ECN system for process improvements.
• Collaborate with internal teams to ensure documentation compliance.

Conocimientos

Document Control

Regulatory Compliance

Cross-functional Collaboration

Bilingual (Spanish and English)

Educación

Bachelor’s degree in Engineering or Business Administration

Herramientas

Microsoft Office Suite

OnePLM platform

Descripción del empleo

Work Flexibility: Onsite

What you will do

Responsible for coordinating and maintaining the documentation processes related to internal and external procedures, policies, and quality standards. You will support the implementation and maintenance of the Engineering Change Notice (ECN) system and ensure alignment across cross-functional teams. This role is key in driving compliance, supporting audits, and ensuring document integrity within the organization.

Responsibilities and Functions

• Coordinate all activities related to document control, maintenance, and updates within the Quality System.
• Implement and maintain the Engineering Change Notice (ECN) system for process improvements, repairs, and new process development.
• Collaborate with Engineering, Manufacturing, Quality, and other areas to ensure changes are properly documented and approved.
• Review documents to ensure alignment with the Quality Management System and applicable regulatory requirements.
• Control and update standard procedures, work instructions, drawings, quality manuals, and other documentation.
• Ensure only the latest versions of documents are available at the point of use and obsolete versions are discarded appropriately.
• Support and lead investigations (NC/CAPA) related to audit findings; assist with internal and external audit readiness.
• Lead or participate in improvement projects and system updates related to document control and change management.

What you need

Required:

• Bachelor’s degree in Engineering, Business Administration or related area
• Minimum of 3 years of experience in Document Control in a medical device or aeroespacial manufacturing environment.
• Demonstrated knowledge of 21 CFR Part 820, ISO 13485, or equivalent medical device regulations.
• Proficient in Microsoft Office Suite, including Word, Excel, PowerPoint, and Power BI.
• Bilingual Spanish and English.
• Availability to work under a 12-month contract.

Preferred:

• Green Belt or Continuous Improvement certification.
• Experience with Quality Systems.
• Experience with OnePLM platform.

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