Director, Quality (Medical Devices)

Location: Alajuela, Costa Rica; the posting also lists Santa Clara, California, United States of America. International travel between Coyol, Costa Rica, and Santa Clara, US, may be required up to 40% of the time.

Company

Johnson & Johnson MedTech develops healthcare and medical device solutions through its Innovative Medicine and MedTech businesses.

What you will do

• Lead the Costa Rica quality organization across quality engineering, quality control, quality systems, document control, calibration, and risk management.
• Implement and maintain the site quality management system and document control functions, coordinating with Santa Clara headquarters.
• Host external quality audits and manage management reviews, CAPA, complaints, nonconformances, internal audits, and supplier audits.
• Oversee QC laboratory operations, inspections, product release, equipment calibration, installation qualification, and preventive maintenance support.
• Coordinate manufacturing-line transfers and validation activities between the Costa Rica and Santa Clara sites.
• Lead quality engineering resources for new products and collaborate with R&D, Regulatory Affairs, and Operations on specifications, process controls, and validation.

Requirements

• Bachelor’s degree in Engineering with 15+ years of relevant engineering experience, or a Master’s degree in Engineering with 12+ years of relevant engineering experience.
• 5+ years of managerial experience with the ability to manage and supervise teams.
• Strong knowledge of medical device regulations and quality management systems, including ISO 13485, ISO 14971, EU MDR, MDSAP, and applicable US and Canadian regulations.
• Strong analytical, problem-solving, communication, leadership, and root cause analysis skills.
• Proficiency in English and Spanish is required.
• Ability to travel internationally between Costa Rica and the United States up to 40% of the time.

Nice to have

• Certified Quality Auditor certification.
• Experience with product or manufacturing-line transfers.
• Experience with budget management, internal auditing, ISO 9001, quality validation, and resource planning.

Culture & Benefits

• Inclusive work environment based on individual dignity, diversity, and merit.
• Cross-functional collaboration with R&D, Regulatory Affairs, Operations, and headquarters personnel.
• Opportunity to lead quality improvements for a medical device manufacturing site.
• Fast-paced environment with changing requirements and multiple priorities.