Principal Document Control Change Analyst (MedTech)

Location: Ciudad Juarez, Chihuahua, Mexico

Company

Johnson & Johnson MedTech develops surgical technologies and personalized, less invasive healthcare solutions.

What you will do

• Analyze and review quality-system document changes, change requests, and change notices for accuracy, consistency, and affected sites or functions.
• Proofread and edit controlled documents for style, grammar, spelling, formatting, and compliance with Good Documentation Practices.
• Execute records-management activities and generate document-control and records-management reports.
• Provide guidance and training to change originators, system users, and internal customers on change-control procedures and system tools.
• Complete required quality-system translations and collaborate with stakeholders to ensure accurate document revisions.
• Support quality-system initiatives, process improvements, and FDA, ISO/TUV, and internal audits.

Requirements

• Bilingual or fluent English and Spanish required.
• High school diploma and/or technical career; near completion or recent completion of a college degree with related experience.
• At least 6 years of experience related to the position, or close to completion of a bachelor's degree.
• Computer proficiency, including Microsoft Word, Excel, PowerPoint, and email.
• Strong verbal, written, active-listening, organizational, prioritization, and collaboration skills.
• Ability to work with policies and procedures, manage multiple projects, and maintain a detailed, methodical approach.

Nice to have

• Experience with electronic change-control processes and PLM systems such as Windchill or ADAPTIV in a regulated industry.
• Knowledge of GMP and ISO standards.
• Experience with quality systems documentation, compliance management, quality validation, report writing, or ISO 9001.

Culture & Benefits

• Inclusive work environment focused on respecting individual contribution, diversity, and dignity.
• Work is performed in accordance with health, safety, environmental, quality, and records-management policies.
• Opportunity to support surgical technologies addressing conditions including obesity, cardiovascular disease, and cancer.