You are required to manage one of Device Verification Design, Device Verification System Development and Field Validation under tight collaboration with Device Vendors, Chipset Vendors, NW Vendors and internal stakeholders.

Great work opportunity at a rare engineering role in automotive OEM! Our client rarely hires as their employee tend to stay for long years. For their infotainment team, they are looking for a Test Manager, that can manage all testing strategies, resources and time table.

You are looking for a stable company where you can work with a great team that has values employees health?
Then this is a great opportunity for you. Our client offers a mid-size team, great leadership, relaxed working hours and encourage their employees to take all their paid leave.

• ISOシステム管理：
• 文書管理データベース（HIMDOC）の管理
• 外部（外部監査機関、顧客）による工場監査ならびに書類監査対応
• QC関連

• Quality control of gas cylinders and raw materials filled in liquefied carbon dioxide filling factories (High Pressure Gas Safety Act, Food Sanitation Act).
• Comply with the High Pressure Gas Safety Act and the Food Sanitation Act, and perform inspections and maintenance of legal equipment requirements based on domestic laws.

• Manages, coordinates, and maintains a virtual supplier network of apheresis and cryopreservation starting material for commercial CAR-T products for Japan.
• Facilitates cell collection site certification activities related to apheresis and cell lab.

• To implement the regulatory strategies and to achieve and maintain all the product registrations based on the company's business plan, local regulations

• Support both vertical and licensed product compliance activities for Japan market. As the PI activities in Japan have expanded, additional support is needed at a senior expertise level that has the ability for senior judgement and decision making under the supervision and leadership of the manager.

• Support and contribute to the implementation of the Product Safety processes in Japan and the zone AP.
• Ensure SDS, DG classification and labelling compliance with local regulations and will support the GBUs in the development of new products/new markets, to ensure global compliance of their products used and placed on the
  Japanese markets.

• Responsible for providing regulatory support and guidance and an efficient regulatory service that is responsive to both internal and external customers and compliant with relevant law.
• Regulatory support on vitamin B3 (non-feed), GMP product, crop-protection products, as well as cosmetic and quasi-drug ingredients.

• Understand company-wide goals and strategies to grow together with customers in the bio-pharmacy market, and carry out activities that contribute to the stable manufacturing and speedy launch of customers' drugs.
• Understand the characteristics of our products used in pharmaceutical manufacturing, responding to quality problems, and proposing quality improvements to their home countries.

• Execute / contribute to build robust QMS and improve product quality to meet customer expectation, and also contribute to launch new Specialty Silicone products

• Lead and manage for ensuring compliance to the applicable regulation (GQP and Medical Device QMS for Japan).
• Take care the overall Quality oversight & responsibility to ensure Quality and Regulatory Compliance of all commercialized products in Japan.

• Ensure company's requirement compliance on Quality & Food Safety, Occupational Safety and Environment through E2E supply chain for KO brand protection.
• Manufacturing quality.

• Issuance & Preparation of new/revised Company's Documents including translation
• Responsible for review the company documents and provide feedback, negotiate with other team.
• Upgrade the translation method to utilize AI translator for accuracy and productivity.

• Manage the line quality and food safety plans to ensure compliance to Right First Time, Targets and finished product standards.
• Promote and facilitate continuous improvement agenda of the site including Quality and Food Safety Management System through effective communication, education, feedback and reviews.

• Responsible for supporting Associate Director Regulatory Affairs EMEA/Japan to ensure compliance with regulations and statutes concerning development, manufacturing, distribution, marketing and sales of company's products in Japan.
• Develops creative approaches and strategies to solve regulatory problems and support company's marketing and business initiatives.

• Provide comprehensive technical support and technology leadership for internal and external customers, for Japan Food and Beverage which includes but not limited too; conducting trials in a laboratory setting and at customers sites, addressing customer inquiries, training, of customers/sales, presentation, problem solving process.

• Customer response, cause investigation, resolution, report preparation when quality problems occur.
• Discuss with the US headquarters and take measures to reduce defective products as much as possible.

• Maintain and manage the quality of new products as well as existing products and their manufacturing process.
• Evaluate and maintain and improve the QC analysis method from hardware and software point of view and collaborate with Operations team and Project/Process Engineering to resolve process and instrument related problems, which requires an in-depth knowledge of the manufacturing process and its integrated control systems.