[의료기기/품질관리] Head of QA - Medical Robot

A global medical device company is looking for a Head of QA - Medical Robot. The selected candidate will develop and implement comprehensive quality strategies, ensure compliance with international standards, and support manufacturing operations.

Responsibilities:

• Lead, mentor, and manage the QA/QE team to support production, validation, and product release processes
• Develop and implement QA/QE strategies aligned with company goals
• Collaborate with various teams to establish and maintain quality standards.
• Work on hiring and onboarding QA/QE staff
• Develop a comprehensive Quality Management System tailored to surgical robotics manufacturing
• Lead the process of obtaining and maintaining ISO 13485 certification
• Conduct gap analyses and develop corrective action plans
• Monitor the effectiveness of the QMS through key performance indicators (KPIs) and quality metrics
• Develop quality control plans for robotic production processes
• Coordinate nonconformance investigations and lead root cause analysis

Requirements:

• Bachelor’s degree or above in Engineering, Quality Management, Life Sciences, Robotics, or a related field (Master’s is preferred)
• More than 15 years of experience in quality assurance or quality engineering within the medical device industry
• More than 5 years of experience in a leadership or managerial role
• More than 2 years of experience with surgical robotics is preferred
• Proven experience in implementing and certifying QMS to ISO 13485 standards, specifically for surgical robots
• Strong knowledge of FDA regulations (21 CFR Part 820), EU MDR, and other global medical device regulations applicable to robotic systems
• Possess a valid ISO 13485 Lead Auditor Certification
• In-depth knowledge of quality management systems (QMS), risk management (ISO 14971), and validation processes (IQ, OQ, PQ) for robotic devices
• Proficient in root cause analysis, statistical methods, and quality tools (e.g., Six Sigma, FMEA), particularly in the context of robotics
• Demonstrated experience in leading certification projects and FDA audit readiness
• Hands-on experience with CAPA, audit processes, and quality control within robotic manufacturing
• Familiarity with lean manufacturing and continuous improvement principles

About the Company:

Based in the United States, this international medical device company specialises in the development of innovative endovascular robotic systems.

Keywords:

의료 기기, 의료, 제조, 품질 보증, 로봇 공학, 기술, 관리, 국제적

Job Ref: HVV86O