Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. **Role Propose:** Manage team with responsibility for providing leadership in establishing, implementing, and maintaining Quality processes and documentation in compliance with domestic and international Regulatory and Quality standards. **Essential Job Function:** + Direct quality activities with responsibilities to establish and maintain compliant and effective Quality management (e.g., CAPA, management review, documentation control, internal and external audit management, training, and complaint handling) including planning, staffing, budgeting, managing expense priorities, recommending and implementing changes to methods through several managers. Drive a culture that is focused on quality and business results. Create an environment that fosters employee motivation and engagement. + Plan and direct strategic quality management activities including prioritizing and selecting appropriate projects with overall responsibility for meeting business objectives. Lead in identifying risk, developing complex mitigation strategies, defining alternative solutions and resolving issues in collaboration with cross functional groups. + Develop robust talent development plan in alignment with functional growth strategies of the department. + Anticipate/eliminate complex quality issues and support timely resolution in collaboration with R&D, Manufacturing Engineering, Operations, Quality, and other departments. + Oversee/direct the development, implementation, and maintenance of training programs to ensure adequate training of personnel on Quality processes and documentation. + Partner and provide strategic guidance to the Japan Management on all operations in the region. Initiate and provide guidance on ways to improve product quality and QMS to meet company goals and quality objectives.Partner with all Business Units in Japan identify the risk and develop solutions in accordance with local regulatory requirements. Partner with Corporate, BUs and Manufacturing sites to resolve quality issues and implement country specific requirements. + Oversee the audit management process of external inspections (e.g. FDA, Notified Bodies, and other regulatory authorities) including; timely closure of post approval commitments, responding to inspection/audit, and resolving open issues with regulatory agencies. **Education / Experience:** + Bachelor's Degree in related science or engineering field with related experience in engineering required and skill levels exceeding the requirements of the previous level is required. + Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry and/or related industry is required + Demonstrated track record in management of quality systems, technical and/or engineering disciplines is required + Master's Degree or equivalent in related field with Experience working in a regulated industry is preferred **Additonal Skill:** + Expert knowledge of company procedures and applicable domestic/international regulations and standards + Expert knowledge of implementation and administration of Quality System processes used in medical device industry + Knowledge of financial acumen as it relates to the business as well as quality engineering + Demonstrated ability to manage teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations + Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality engineering to the business + Serve as core partner to senior leadership in Business Units, Functional Groups, Regions and IT + Strict attention to detail + Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization + Ability to work and excel within a fast paced, dynamic, and constantly changing work environment + Interacts with senior management, and others concerning matters of significance to the company + Conduct business and technical briefings for senior and top management and for external representatives + Regularly interacts with executives and/or major customers; interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization + Dedicated to quality client service and pro-active and responsive to client needs. + Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness. + Provide leadership and direction to large cross-functional teams to successfully implement global enterprise systems and related solutions + Develop relationships and leverage them to influence change + Support and solicit input from team members at all levels within the organization + Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control