カントリーQAマネージャー/ Country QA Manager

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

About the Company:

A global consumer goods manufacturer known for its trusted household and personal care brands, delivering high-quality products backed by strong research, innovation, and sustainable practices. The company offers stable career opportunities, a collaborative work culture, and clear paths for professional growth within a respected international organisation.

Keywords:

品質保証マネージャー, 医療機器, 品質管理システム, 規制対応, 外資系医療機器メーカー, 品質監査, 求人, 外資系

Job Ref: 692UYG