Third Party Management Engineer (PR-34025014)
Job Type: Permanent
As a part of global technical group, independently executes small－ to medium－size product and process changes within engineering specialty using established procedures. Prepares and communicates recommendations and respective action plans. Follows through on project goals. Ability to analyze phenomena based on scientific or engineering theory and present solutions while looking at the problem from a bird's－eye view. Strive to provide support from technical area to enhance the business. Oversee and coordinate daily operations and maintain compliance with external regulations and internal policies Independently investigates, conducts tests or experiments, gathers data, performs preliminary analysis, and reports findings. Makes recommendations for improvements. Executes formal Change Requests in the Quality System associated with assigned projects. Conveys information effectively through formal and informal documents with team members, designers, technicians, and other technical personnel, both internal and externally, using appropriate communications protocols, eg, develops proposals, conducts reviews.
Interfaces with internal company contacts (Quality, Supply Chain, Regulatory, R&D. Communicates very frequently with external contacts from the assigned organizations on routine matters. Complies with all regulations and standards for Quality, Environmental, Health, Safety, and Energy (EHS&E) Global Policies, Engineering Standards, and other governance areas as applicable. Ensures quality and effectiveness of assigned tasks. Identifies areas of risk with respect to compliance . Develops and executes validation protocols. Resolves problems, such as production process deviations, vendor deviations from specification, urgent out－of－stock replacements, and crisis situations requiring fast, astute decisions with rapid implementation by utilizing technical training and experience.
Bachelors degree from an accredited college Master's or Ph.D. is preferred Engineering, Science or related fields Required Skills: Bachelors Degree in Engineering (in mechanical, electrical, control, IT and software etc.), science or closely related discipline (Master degree is preferred), OR an equivalent combination of education and work experience. Minimum 4 years industrial experience. English and Japanese, with the ability to clearly communicate complex information across all levels of the organization.
Preferred Skills: ・ Degree in Biomedical engineering, chemical engineering, chemistry/biochemistry or related discipline preferred. ・ 5-years prior medical device (IVD) experience with knowledge of regulation and standards as they pertain to the design, integration, evaluation, and commercialization of diagnostic systems ・ Experience in design/change control and risk management for products preferred. ・ Experience working with third-party vendors and customers. ・ Statistical analysis and data visualization experience for investigation of customer/vendor issues/trends. ・ Exposure to manufacturing processes as it applies to multi-component assembly operations.
Progressive Recruitment is part of the larger SThree K.K group
Award winner of:
Best Large Company to Work For by TIARA Awards 2021 | Best CSR Initiative by TIARA Awards2019 | Best Workplace by Great Place to Work Institution 2018, 2020 & 2021