Quality Operations Lead - MedTech & Compliance

Johnson & Johnson Innovative Medicine; Ciudad Juárez; Presencial; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Johnson & Johnson Innovative Medicine in Ciudad Juárez is seeking a Quality Operations Manager to plan, coordinate, and direct QA programs ensuring continuous production aligns with established standards.

You will lead quality improvement initiatives, manage audits and regulatory compliance, and collaborate with NPI and operations on validation strategies. Strong English communication and leadership are required.

Formación

• Master or Doctorate in applicable sciences.
• 8 to 10 years of work experience, or demonstrated performance.
• Excellent communication skills in English, spoken and written.
• Ability to effectively deal and negotiate with representatives of various governmental agencies and auditing agencies.
• Certifications such as CQA, CQE, CQM are a plus.

Responsabilidades

• Leads quality improvement initiatives, including process and product improvements.
• Revises and approves Engineering Change Orders (ECOs).
• Reviews audits to ensure compliance with regulatory requirements (QSRs, ISO 13485).
• Defines, monitors and administers the department budget.
• Collaborates with NPI and operations for validation strategies of products and processes.
• Provides guidance in MRB and CAPA investigations and corrective actions.

Conocimientos

Compliance Management

CAPA

Cross-Functional Collaboration

Developing Others

Fact-Based Decision Making

Give Feedback

GMP

Inclusive Leadership

ISO 9001

Leadership

Quality Control

Quality Management Systems

QMS

Quality Standards

Quality Validation

SOP

Tactical Thinking

Team Management

Educación

Master's degree in applicable sciences

Doctorate in applicable sciences

Herramientas

Computer packages

Descripción del empleo

Johnson & Johnson Innovative Medicine in Ciudad Juárez is seeking a Quality Operations Manager to plan, coordinate, and direct QA programs ensuring continuous production aligns with established standards.

You will lead quality improvement initiatives, manage audits and regulatory compliance, and collaborate with NPI and operations on validation strategies. Strong English communication and leadership are required.