Director, Quality

Johnson & Johnson is seeking a Director, Quality to join their team in Costa Rica.

About the role

The Director of Quality will be responsible for the administration, supervision, and development of the Quality group in Costa Rica. They will provide leadership for the organization's quality engineering, quality control, quality systems and document control, calibrations, and risk management program. The Director of Quality will develop and implement procedures and systems to assure Shockwave Medical, Costa Rica complies with applicable regulatory standards such as: ISO 13485 – Medical Devices – Quality Management Systems, 21 CFR 820 and 21 CFR 803, ISO 14971, Application of Risk to Medical Devices, Council of the European Communities Directive 93/42/EEC - Medical Device Directive, Current Good Manufacturing Practices (CGMP), Quality Systems Regulation, EU MDR – European Medical Device Regulation (MDR), MDSAP and other relevant geography regulations, CMDR - Canadian Medical Devices Regulations.

Responsibilities

• Site Establishment: Directly responsible for the implementation of a Quality Management System for the Shockwave CR site and document control functions for the Shockwave CR site.
• Interfaces with Santa Clara (headquarters) personnel to ensure continued compliance to overall corporate and Costa Rica site specific requirements.
• Captures and coordinates with the Shockwave-Santa Clara site to support the transfer and validation of manufacturing lines at the Shockwave-CR site.
• Compliance: Acts as the Quality Representative, and host, for external Quality audits (eg: FDA, BSI, JJRC).
• Plans and executes for Management Reviews for the Shockwave CR site.
• Ensures that product and process changes are approved by Santa Clara personnel prior to implementation at the Shockwave CR site.
• Manages, executes, and makes improvements to the following quality system activities: CAPA, Complaints and NCRs, Internal Audit Program, Supplier Audits.
• Operations: Supervises, manages, Document Control, Quality Engineers, Quality Compliance Specialists, QC Supervisor, and provides general oversight of the entire QC Technician Team.
• Led the Document Control functions and related responsibilities, including, but not limited to, Lot History Record review and standards management.
• Manages the QC testing lab, applies statistical and engineering techniques to determine sampling parameter testing requirements, oversees equipment calibration program, supports equipment installation qualification and preventative maintenance program, oversees incoming, in-process and final product inspection and final product release to distribution activities.
• Manages employee training and development, and maintains and supports improvements to employee training in QSR and ISO regulations.
• Interfacing with R&D, RA, and Operations to interpret Engineering requirements, and to draft, review and approve specifications for products, processes and components.
• Manages quality engineering resources for new products, directs or provides input, including statistics, to Process Validations and Verification activities and planning.

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.
• Excellent understanding of medical device regulations, medical device quality management systems, supervisory or project management skills and strong quality knowledge and experience.
• Certified Quality Auditor is a plus, but not required.
• Ability to travel internationally between Coyol (Costa Rica) and Santa Clara (US) up to 40% of the time.
• Strong analytical and problem-solving skills.
• Ability to effectively manage and supervise teams.
• Prior experience in product / manufacturing line transfers is a plus.
• Excellent communication and leadership skills.
• Proficient in English and Spanish.
• Strong written and oral communication skills.
• Ability to work in a fast-paced environment while managing multiple priorities.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.