Director of Quality

About the role

Johnson & Johnson’s Shockwave Medical in Costa Rica is seeking a Director of Quality to lead the quality organization. The role oversees quality engineering, control, systems, document control, calibrations and risk management, ensuring compliance with global medical device regulations.

Key responsibilities

• Implement and maintain the Quality Management System for the Shockwave Costa Rica site, coordinating with headquarters to meet corporate and site‑specific requirements.
• Lead external audits (FDA, BSI, JJRC) and conduct internal management reviews, CAPA, complaint and NCR handling, and supplier audits.
• Supervise the Quality team—including Quality Engineers, Compliance Specialists, QC Supervisor and technicians—and drive continuous improvement in the QC laboratory.
• Oversee equipment calibration, installation qualification, preventative maintenance, and product inspection and release activities.
• Manage product and process change approvals, support manufacturing line transfers, and provide technical input for process validations and verifications.

Required profile

• Bachelor’s degree in Engineering with 15+ years of relevant experience (or Master’s with 12+ years) and at least 5 years of managerial experience.
• Deep knowledge of medical‑device regulations (ISO 13485, 21 CFR 820/803, ISO 14971, EU MDR, MDSAP, CGMP, etc.).
• Proven ability to travel internationally up to 40 % of the time and to work in a fast‑paced, multi‑project environment.
• Fluent in English and Spanish with strong written and oral communication skills.

Required skills

• ISO 13485, ISO 14971, EU MDR, MDSAP, CGMP compliance.
• 21 CFR 820 and 21 CFR 803 regulatory knowledge.
• CAPA management, internal and supplier auditing.
• Document control, SOP development, risk management.
• Statistical analysis and equipment calibration techniques.