Quality Compliance Specialist II

About the role

The Quality Compliance Specialist II supports Shockwave Medical’s quality processes in Alajuela, Costa Rica. Working under supervision, the specialist ensures that procedures meet regulatory and industry standards while collaborating with cross‑functional teams across Shockwave sites.

Key responsibilities

• Coordinate and manage escalated quality issues, guiding thorough investigations and tracking documentation.
• Support planning and execution of field actions, communicating with stakeholders and monitoring effectiveness.
• Assist in developing and executing quality plans, reporting status and progress.
• Conduct gap assessments against FDA/EU/ISO regulations and industry standards, and help implement corrective strategies.
• Develop and maintain local SOPs, provide training on quality processes, and participate in cross‑departmental improvement projects.
• Support quality system initiatives, audits, and continuous improvement activities.

Required profile

• Ability to coordinate escalated issues and work with multiple departments.
• Experience supporting field actions and quality planning activities.
• Familiarity with regulatory standards such as FDA, EU, and ISO.
• Strong collaboration skills across functional teams.

Required skills

What we offer

• Opportunity to work within a global healthcare leader.
• Exposure to cutting‑edge medical device quality processes.
• Collaborative environment that values diversity and inclusion.