Job Description Summary

Job Description

• Accountable for the Quality Assurance department operation and the company’s Quality Management system, drives continuous improvement initiatives, and maintains effective communication with internal and external stakeholders.
• Ensure that products manufactured at the Fukushima facility are safe, efficacious and perform as intended, and determines whether products conform to specifications, country regulations and industry standards.
• The position reports directly to Senior Director of Manufacturing & Design Quality, Greater Asia

Roles / Expectation

• Develops and maintains plant-wide quality standards, procedures, and processes to ensure compliance with regulatory (local and international), corporate, and business unit requirements.
• Appointed as Management Representative (MR) and representing management during audit. Lead the Quality Management Reviews, presenting detailed reports on the performance of the quality system and quality objectives to the leaders. Provide actionable insights and recommendations for continuous improvement.
• Serve as the primary interface between the plant and Divisional, Corporate, and external quality-related personnel, ensuring effective communication and collaboration on all quality matters.
• Provides leadership in quality oversight and direction, scheduling, decision-making, problem-solving, and team-building capabilities.
• Prepare the company for audits and inspections from regulatory authorities, ensuring inspection readiness and compliance at all times. Lead audit response and resolution efforts, maintaining a strong track record of successful inspections.
• Maintain meticulous documentation practices in accordance with regulatory standards. Oversee the company's documentation function, ensuring accuracy, completeness, and accessibility of quality-related records.
• Plans and manages departmental budget, contributing to the development of overall business strategies.
• Lead the review of non-conformances, collaborating with the cross functional team to initiate corrective and preventive action plans. Ensure root cause analysis and sustainable solutions are implemented promptly.
• Provides Quality Assurance oversight for all product lines, ensuring adherence to specifications and effective handling of non-conforming products.
• Manages customer complaints, implements corrective actions, and communicates effectively with customers.
• Manages Internal and Supplier audit programs.
• Supports evaluation projects and new projects by guiding the development of quality plans and executing inspection and testing activities.
• Participates in steering team meetings to set direction and expectations for resource and process teams, driving continuous improvement and team development.
• Perform any other tasks as assigned.

Primary Work Location

Additional Locations

Work Shift