Quality Engineer

About the role

TCS Costa Rica is seeking a Quality Engineer to support its worldwide Service Centers in the medical device sector. The role focuses on ensuring compliance with ISO 13485 standards, driving cost‑improvement initiatives, and managing transformation projects.

Key responsibilities

• Act as the primary contact for quality and compliance matters across global Service Centers.
• Support cost‑improvement initiatives and transfer projects while maintaining regulatory compliance.
• Ensure consistent execution of quality system procedures at DPS Service Sites.
• Collaborate with Service Operations and Supply Chain to harmonize service processes globally.
• Partner with Customer Quality teams to meet reporting requirements and handle customer complaints.
• Track monthly performance and quality metrics for each DPS site.
• Coordinate resolution of nonconformances, CAPAs, and audit observations related to installation and services.
• Update and harmonize procedures for global service alignment.

Required profile

• Minimum 3 years of experience in a regulated medical device environment (ISO 13485).
• Advanced English proficiency for interviews and daily communication.
• Experience in quality, manufacturing, or service and repair functions.
• Strong project management and problem‑solving abilities.

Required skills

• Lean Six Sigma Green Belt or Black Belt.
• Project Management Certification.
• ASQ CIA or CQE certification (preferred).
• In‑depth knowledge of ISO 13485 and medical device regulatory requirements.

What we offer

• 100% payroll under local law.
• Direct contract employment.
• Hybrid work modality.