品質保証マネージャー/ QA Manager

A renowned wellness company is looking for a QA Manager. The selected candidate will lead quality management system oversight, regulatory compliance, audits, product registration support, and continuous quality improvement across the business. This is a hybrid role.

Responsibilities:

• Oversee the quality management system and monitor KPI performance across the facility
• Implement and maintain QMS processes while driving standardisation and continuous improvement
• Lead internal, external, vendor, notified body, and regulatory audits to ensure full compliance
• Support product registration, regulatory submissions, and documentation for existing and new product lines
• Monitor customer complaints, adverse events, product inspections, and shipment release activities
• Advise internal stakeholders on QMS requirements and promote company-wide quality improvement initiatives

Requirements:

• Bachelor’s degree or above in Science, Engineering or similar technical discipline
• 5-7 years of experience in Good Manufacturing Practice (GMP), encompassing Quality Management or Compliance role
• Experience of supporting the introduction of new products
• Understanding of ISO 13485, 9001 and Japan MHLW and PMDA and related requirements
• Possess valid qualification as a licensed Supervisor for Product Classification under Japanese regulations (including medical device Class 1 and cosmetics)
• Professional level Japanese; proficient in English

About the Company:

A wellness-focused company offering innovative health and lifestyle products designed to support overall vitality and performance. Combines research-driven solutions with a global distribution network to serve a diverse and growing customer base.

Keywords:

品質保証、品質管理、品質マネジメントシステム（QMS）、監査支援、薬事規制対応、製品登録、規制遵守、品質改善、求人, 外資系

Job Ref: 58N84Y