Job Description

Locations

• Costa Rica, Grecia

Skills Required

• Quality Engineeringintermediate
• Quality Management System Regulationintermediate
• medical device industryintermediate

Required Qualifications

• Bachelor’s degree in Engineering or a related technical field. (degree in engineering or a related technical field)
• Minimum 7 years of experience in Quality Engineering, Technical Services, Microbiology, Sterilization, Calibrations, Receiving Inspection, or related quality functions within a regulated industry. (experience, 7 years)
• Minimum 2 years of people leadership experience. (experience, 2 years)
• Knowledge of Quality Management System Regulation (QMSR), ISO 13485, and Medical Device Single Audit Program (MDSAP) requirements. (experience)
• Experience leading root cause investigations, corrective and preventive actions, and nonconformance management processes. (experience)
• Fluent English proficiency. (experience)

Preferred Qualifications

• Experience in the medical device industry. (experience)
• Experience managing laboratory operations, quality systems, or technical services teams in a manufacturing environment. (experience)

Responsibilities

• Lead technical services activities across Metrology, Microbiology, Receiving Inspection, and related laboratory operations to ensure compliance with quality and regulatory requirements.
• Manage and develop a team of engineers and quality professionals, supporting talent growth, performance management, and organizational scalability.
• Oversee investigations of complex product and process quality issues using root cause analysis methodologies and corrective and preventive action processes.
• Provide subject matter expertise in microbiology, sterilization, calibrations, receiving inspection, and quality systems.
• Monitor quality performance metrics, including defects, yield, scrap, nonconformances, and complaints, and implement improvement actions based on data analysis.
• Ensure compliance with applicable regulatory and quality standards, including Quality Management System Regulation, ISO 13485, and Medical Device Single Audit Program requirements.
• Support cross-functional projects, laboratory expansion initiatives, and operational readiness activities while meeting project timelines and deliverables.
• Serve as the operational backup for the Technical Services leader, ensuring continuity of decision-making, prioritization, and execution across the organization.

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