Plant Quality Leader/QA Manager

Responsibilities

• Accountable for the Quality Assurance department operation and the company’s Quality Management system (QMS).
• Drive continuous improvement initiatives and maintain effective communication with internal and external stakeholders.
• Ensure all products manufactured at the Fukushima facility are safe, efficacious, and conform to specifications, country regulations, and industry standards.
• Act as the Management Representative (MR) during audits and lead Quality Management Reviews.
• Prepare the company for regulatory authority audits and inspections, leading response and resolution efforts.
• Oversee the company's documentation function to ensure accuracy, completeness, and accessibility.
• Lead the review of non-conformances and collaborate with cross-functional teams to implement corrective and preventive action (CAPA) plans.
• Manage customer complaints and implement necessary corrective actions.
• Manage internal and external supplier audit programs.
• Provide leadership, coaching, and talent management for the quality team.

Requirements

• Bachelor’s Degree in Science or Engineering.
• 5-7 years of experience in the regulated medical device industry, specifically focused on manufacturing quality.
• Minimum of 2 years of people managerial experience within the medical device industry.
• Proficiency in both Japanese and English with strong interpersonal and presentation skills.
• Deep knowledge of PMD Act, QMS ordinances, and ISO 13485/9001.
• Proven experience preparing for and leading government regulatory inspections and customer audits.

Preferred Qualifications

• Six Sigma Green-belt or Black-belt certification.
• Strong background in statistics and technical problem-solving.
• Experience executing functional strategies and managing key strategic metrics (KPIs).

About the Company

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. We look at the impossible and find transformative solutions that turn dreams into possibilities.