Corporate Quality Principal Auditor (MedTech)

Location: South Korea, Japan, Taiwan, or Dubai, United Arab Emirates

Company

hirify.global develops healthcare technologies and maintains global quality and regulatory systems supporting its mission to enable healthier lives.

What you will do

• Support and improve the global Quality Audit program, including audit metrics, processes, and reporting.
• Plan and lead risk-based corporate compliance audits, special audits, gap assessments, supplier audits, acquisition audits, and transfer audits.
• Analyze audit data and prepare detailed and executive-level reports, trend analyses, and annual compliance audit reports.
• Identify compliance risks and drive improvements to manufacturing processes and Quality Management Systems.
• Support FDA inspections and external audits, including front-room and back-room activities.
• Coach teams and partner with Manufacturing, Quality Engineering, R&D, Compliance, and Quality Operations.

Requirements

• Bachelor’s degree in Engineering, Science, or a related technical discipline.
• At least 5 years of experience as a Principal or Lead Auditor in a regulated industry, with current certifications.
• At least 3 years of experience in manufacturing, quality engineering, R&D, compliance, quality operations, servicing, refurbishing, chemical compliance, clinical studies, or an equivalent area.
• Strong knowledge of 21 CFR 820/QMSR, ISO 13485, MDSAP, FDA regulations, ISO 14971, ISO 19011, ISO 14155, EU MDR, EU IVDR, REACH, RoHS, and Conflict Minerals.
• Experience with risk assessment, audit findings, corrective actions, CAPA, root cause analysis, validation activities, and systemic quality improvements.
• Active Lead Auditor certification from a recognized accreditation company is required.

Nice to have

• Additional global regulatory knowledge and awareness of AI-related healthcare regulations.
• GCP/GLP understanding or multilingual capability.

Culture & Benefits

• Access to tools, training, and knowledge needed to perform the role.
• Continued professional development and training throughout the career.
• Opportunity to strengthen quality systems and regulatory confidence across global operations.