Director, Quality

About the role

The Director, Quality will lead the Quality function for Shockwave Medical in Costa Rica, overseeing quality engineering, control, systems, and risk management. This senior position ensures compliance with global medical‑device regulations and drives continuous improvement across the site.

Key responsibilities

• Implement and maintain the Quality Management System (QMS) for the Costa Rica site.
• Coordinate with the Santa Clara headquarters to align site‑specific and corporate quality requirements.
• Lead external quality audits (FDA, BSI, JJRC) and prepare management review meetings.
• Approve product and process changes in collaboration with headquarters.
• Manage CAPA, complaints, non‑conformance reports, internal audits, and supplier audits.
• Supervise document control, calibrations, and risk‑management activities.
• Support transfer and validation of manufacturing lines to the Costa Rica site.

Required profile

• Proven leadership experience in quality management within the medical‑device industry.
• Deep knowledge of global regulatory standards (ISO 13485, 21 CFR 820/803, ISO 14971, EU MDR, MDSAP, CMDR).
• Ability to work cross‑functionally with headquarters and external auditors.
• Strong analytical and problem‑solving skills with a focus on continuous improvement.

Required skills

• ISO 13485 implementation
• 21 CFR Part 820 compliance
• ISO 14971 risk management
• EU MDR knowledge
• MDSAP familiarity
• CMDR familiarity
• CAPA management
• Document control systems