Quality Operations Leader - MedTech Process Innovator

Biopharma Careers; Ciudad Juárez; Presencial; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Johnson & Johnson is seeking a Quality Operations Manager for the Horizontes site in Ciudad Juarez, Mexico. You will lead quality assurance programs, manage regulatory readiness, and oversee MRB, CAPA, and NC activities to ensure products meet the highest standards.

This role requires extensive QA experience and strong English communication skills. As a key member of the Electrophysiology division, you will partner with operations and engineering to validate processes, implement improvements,

Formación

• 8 to 10 years of work experience
• Master or Doctorate in applicable sciences
• Excellent communication skills in English, spoken and written

Responsabilidades

• Leads or supports quality improvement initiatives and continuous improvements
• Revises and approves engineering change orders (ECOs) and CAPAs
• Ensures compliance with QSRs, ISO 13485 and other relevant regulations
• Prepares for regulatory audits and acts as SME or Escort
• Defines and monitors department budget
• Collaborates on NPIs and validation strategies
• Manages MRB and NCs investigations, CAPAs, and customer complaints
• Oversees risk assessment and FMEA activities
• Drives quality engineering and lifecycle management for products

Descripción del empleo

Johnson & Johnson is seeking a Quality Operations Manager for the Horizontes site in Ciudad Juarez, Mexico. You will lead quality assurance programs, manage regulatory readiness, and oversee MRB, CAPA, and NC activities to ensure products meet the highest standards.

This role requires extensive QA experience and strong English communication skills. As a key member of the Electrophysiology division, you will partner with operations and engineering to validate processes, implement improvements,