Quality Systems Manager (Medical Devices)

Location: Onsite in Ciudad Juarez, Chihuahua, Mexico

Company

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

What you will do

• Manage NCR and CAPA processes and systems across manufacturing operations sites.
• Drive quality systems and compliance improvements based on internal and external audits, management reviews, and quality indicators.
• Lead data review forums, effectiveness monitoring, education, mentoring, and continuous improvement for NCR and CAPA systems.
• Coordinate product complaint evaluations, risk assessments, product performance trending, and escalation to CAPA.
• Lead or participate in interactions with FDA, TUV, and Johnson & Johnson quality assurance teams during audits and information requests.
• Develop quality personnel, coordinate training, manage staffing needs, oversee department spending, and partner with cross-functional leaders.

Requirements

• Bachelor’s degree or equivalent.
• 8–10 years of related experience.
• Bilingual English and Spanish required.
• Knowledge of QSR, ISO, and other regulatory requirements.
• Demonstrated project management, communication, influencing, presentation, and results-oriented skills.
• Experience with Windows-based business software, networked environments, quality management systems, and regulatory compliance.

Nice to have

• Medical device industry experience.
• Process Excellence, Six Sigma, Lean, or Design Excellence training; Green or Black Belt certification is highly desired.
• Supervisory experience, CAPA leadership, and experience with external auditing bodies.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and employee development.
• Structured training and periodic retraining for employees and direct reports.
• Strong emphasis on health, safety, environmental compliance, and safe workplace practices.
• Opportunities to improve professional skills through process excellence and professional certifications.