Country QA Manager

Job Description A multinational medical device company is looking for a Country QA Manager. The selected candidate will oversee quality systems, ensure regulatory compliance, support new product launches, and lead quality initiatives across business functions. This is a hybrid setup role. Responsibilities: - Lead implementation of corporate QMS integration initiatives - Build strong cross-functional relationships across commercial, R&D, supply chain, and technology teams - Drive strategic quality initiatives and translate plans into actionable outcomes - Ensure quality and compliance across all business operations in line with corporate policies - Oversee the local Quality Management System and monitor performance metrics - Escalate quality issues and coordinate appropriate corrective actions - Ensure adherence to new regulatory and quality requirements - Establish and maintain audit systems in line with PMDA, MDSAP, ISO, and QSR standards - Act as lead auditor and manage documentation, tracking, and follow-up actions - Assess product quality impact and lead investigations into customer complaints - Provide guidance on quality and measurement methods across teams - Manage quality system procedures and ensure proper documentation and record-keeping - Maintain ethical standards and compliance with corporate policies Requirements: - Bachelor's degree or above in Engineering, Quality, or Science - More than 8 years of technical experience - More than 3 years of supervisory experience - Prior experience in consumer products and medical devices - Experience in medical device risk management under ISO14791 - Knowledge of PMDA, MDSAP, ISO13485, and Quality System Regulation standards - Proven ability in quality evaluation and controls for electromechanical medical devices - Ability and willingness to travel domestically - Professional level Japanese and English