Sr. Quality Operation Engineer - Heart Recovery

About the role

The Sr. Quality Operation Engineer/Specialist oversees and executes all Quality Operations activities, ensuring that products and processes meet internal and external quality standards and regulatory requirements. The role supports the integrity of the Quality Management System and continuous improvement at third-party logistics (3PL) providers and distributors, and reports directly to the Sr. QA Manager.

Key responsibilities

• Lead product-related Quality Notifications (QNs) and their investigations in collaboration with the US team, and close QNs and CAPAs on time
• Address customer-impacting issues and prioritize solutions focused on quality and compliance
• Manage incoming inspections, product releases and storage activities at 3PL providers
• Develop and improve processes at 3PL and distributors, and improve QMS processes such as nonconformance management and CAPAs
• Oversee calibration and management of measuring equipment used by QA
• Communicate business issues or opportunities to management and follow HSE guidelines

Required profile

• Minimum 3 years of experience in quality assurance within the medical device industry or a related field
• Basic knowledge of the Japan PMD Act, QMS Ordinance and ISO 13485:2016
• Fluency in Japanese and basic written and spoken English

Required skills

• Basic analytical and problem-solving skills
• Strong communication and interpersonal skills
• Basic PC skills: Excel, Word, PowerPoint and PDF