Jobs in Japan
Explore hand-picked jobs in Japan for English speakers across tech, education, marketing, and more.
Vetted companies only. Apply from overseas.
Jobs in Japan
Explore hand-picked jobs in Japan for English speakers across tech, education, marketing, and more.
Vetted companies only. Apply from overseas.
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 all 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. 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 External 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. Identify, develop and managing talents/ direct reports/ team for advancement/ redeployment. Perform any other tasks as assigned. Manage quality team and ensure that assigned team members are developed individually as well as collectively.
- Minimum of a Bachelor’s Degree in Science or Engineering. - With a minimum of 5-7 years of experience to work in regulated medical device industry, with a focus on manufacturing quality. - With a minimum of 2 years of people managerial experience in regulated medical device industry, in manufacturing or similar capacity. - Proficient in both Japanese and English with exceptional interpersonal and presentation skills. - High adaptability, strong technical, problem solving and statistics background. - Self-initiative, objective driven, embracing and proactive attitude with minimum supervision. - Project management skill. - Depth knowledge of PMD Act, QMS ordinances, ISO13485/ 9001 and other applicable regulation and guidance. - Experience in preparing, hosting and lead Governments’ Regulatory inspection and customer audit. - Experience in execute business/ functional strategy, key strategic objectives / metrics while aligning priorities and resources to deliver on commitments.
- Six Sigma Green-belt / black belt or other CI related skills will be considered as added skill.
- A culture in which you can learn, grow and thrive. - Face-to-face collaboration that supports your learning, progress, and success.
