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Johnson & Johnson MedTech is seeking a Document Control Change Analyst, Principal for its Ethicon surgical innovation division in Ciudad Juárez. This role is central to ensuring the integrity and compliance of the quality system documentation and product lifecycle management (PLM) processes.
You will analyze and review documentation changes, ensuring accuracy, consistency, and adherence to regulatory standards (GMP, ISO, FDA). Key responsibilities include:
• Analyze documentation changes based on description, rationale, and affected sites/functions
• Review Change Requests and Change Notices for accuracy and timeliness
• Proofread and edit documents for style, grammar, spelling, and format compliance with Good Documentation Practices (GDPs)
• Complete Quality System policy and procedure translations as required
• Collaborate with relevant personnel to ensure accuracy of document revisions
• Provide training and guidance to change originators, system users, and internal customers on change control processes and system tools
• Execute and support Records Management program activities and procedures
• Generate Document Change Control and Records Management reports
• Support Quality Systems initiatives, process improvements, and audits (FDA, ISO/TÜV, internal)
• Ensure compliance with Environmental Management System (EMS) responsibilities and all J&J Records Management policies
• Communicate business issues and opportunities to management
This is a professional-level role within Johnson & Johnson's quality and compliance infrastructure, supporting the development of next-generation surgical technologies and treatments.
QUALIFICATIONS & REQUIREMENTS:
Education: High school diploma and/or technical career; close to completion of college degree or recently completed degree with related work experience required.
Experience: 6+ years in a related position, or close to completion of a bachelor's degree (preferred). Knowledge and skills to satisfactorily develop position responsibilities.
Required Knowledge, Skills & Abilities:
• Bilingual/fluent in English and Spanish (required)
• Computer skills and proficiency in Microsoft Office (Word, Excel, PowerPoint, Email)
• Ability to learn software applications for Document & Data Control (PLM systems)
• Experience with electronic change control processes and PLM systems (Windchill, ADAPTIV, etc.) in regulated industry (highly desirable)
• GMP/ISO knowledge (preferred)
• Strong verbal, written, and active listening skills
• Ability to organize, prioritize, and manage multiple projects simultaneously
• Ability to communicate effectively and professionally with all organizational levels and functional groups
• Ability to work collaboratively or independently with attention to detail and methodical approach
• Accountability, compliance management, process orientation, quality control expertise, and report writing capability
