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<\/p> \u8077\u7a2e
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The purpose of this role is to provide Quality and Regulatory expertise to support local\/regional\/international business objectives as well as provide guidance to employees to facilitate continuous quality improvement. There are two primary roles: 1) critical in supporting the launch and lifecycle of commercialized products including localization, Distribution Center and Safety Management operations in compliance with Japanese regulations and Global QMS standards 2) ensures compliance with Quality System activities (programs, policies, processes, procedures) to achieve stated objectives.Key Responsibilities:\u2022 As Sokatsu (General Marketing Supervisor), is responsible for overseeing manufacturing, sales, and post-market safety management of medical devices. Ensure compliance with quality standards and take overall responsibility for product quality and safety.\u2022 Maintains, advises and reports on compliance to Corporate Quality System, International and Local Requirements and Regulations as well as Quality Policies and Procedures to site Management Team and other employees on how to achieve compliance for the aforementioned Quality System elements, as applicable to the site;\u2022 Promotes and develops quality awareness in every employee, while helping the site organization towards improved quality performance and ownership as well as customer and regulatory\/compliance oriented initiatives;\u2022 Monitors, identifies and reports on key Quality System indicators and takes appropriate action to address areas for improvement; May verify implementation of suggested solutions; Is responsible for continuous Quality System efficiency and effectiveness and promoting solution-driven behavior;\u2022 Frequently interacts with and represents the quality function to certain departments like Operations, Regulatory, Sales and others, as key Quality System processes are managed by those areas (e.g. Complaint reporting, Field Action execution, etc) - May also interact with national regulatory authorities;Quality System Requirements:In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.For those individuals that supervise others, the following statements are applicable:\u2022 Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.\u2022 Establishes and promotes a work environment that supports the Quality Policy and Quality System.
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Key Requirements:
\u2022 Experienced Quality Director in a medium to large Medical Device Company; covers all aspects of QMS
\u2022 Experience leading Sr. Managers (results through other people leaders)
\u2022 Meets the qualifications of being a Sokatsu \u2013 previous experience preferred
\u2022 Expertise in MAH requirements\/QMS Ordinance, ISO 13485, ISO 14971
\u2022 Strong English skills (both verbal and written)
\u2022 Track record of driving change in an organization
\u2022 Ability to think beyond \u201crequirements\u201d with ability to balance patient safety, quality, and business needs; innovative thinker
\u2022 Team builder \u2013 Good at helping to build community\/develop talent\/inspire
Strong collaboration skills \u2013 especially an ability to build partnerships with other functions
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<\/p> show more","tags":"","url_out":"https:\/\/ja.jooble.org\/desc\/1442525363436389244?ckey=quality-assurance&rgn=-1&pos=6&elckey=-1562990063607619032&pageType=20&p=1&sid=739573002660873257&jobAge=3903&relb=100&brelb=100&bscr=8076.1104&scr=8076.1104&iid=-3817078129129955026","salary":"","currency":"JPY","pubDate":1751552894,"expDate":1754144894}