1. Assist management in the development, implementation, and maintaince of software and cybersecurity framework and procedures to maintain and ensure compliance with medical device regulatory requirements. 2. Coordinate, compile, and maintain U.S, and/or International regulatory facility registrations, product listings/licenses and other country specific product registrat

Administers a designated sales territory with the support of corporate and field members to achieve the annual sales objectives established by the Regional Sales Director. Manage and make all necessary entries in the Customer Relationship Management (CRM) program to maintain all accounts information complete and up to date. Formulate and implement a detailed Territory Pla

Provide customer support through email and phone calls via ZenDesk and Five9. Manage a sales region of service contracts and software maintenance agreements throughout lifecycle. Set up new warranty contracts in Metrix upon instrument installation. Generate service renewal contracts, reviewing terms of new contract against master or original sale contract. Validate data,

1. Supports the development and maintenance of key aspects within Sysmex's quality systems, designed to meet the Quality Management System requirements and ensure compliance with Regulatory requirements. 2. Day to day management and coordination of (any of these can apply) Coordinate effective corrective and preventive (CAPA) actions with various business owners, includin

Successfully complete all training to perform the duties of a Service Engineer (SE). During training program, travel to various U.S. service districts to work with a mentor or assist with SE related tasks. Upon successful completion of the training program, work as an SE in various service districts as needed for periods up to six months. Travel during the training period

1. Maintain product knowledge on all SAI supported instruments in order to analyze and identify instrument problems. 2. Adhere to all SAI and department standard operating procedures and documentation requirements to meet regulatory and ISO guidelines. Such as, escalated calls when appropriate and monitor TAC voicemails, auto generated errors, dispatches and overflow call

Successfully complete all training to perform the duties of a Service Engineer (SE). During training program, travel to various U.S. service districts to work with a mentor or assist with SE related tasks. Upon successful completion of the training program, work as an SE in various service districts as needed for periods up to six months. Travel during the training period

Successfully complete all training to perform the duties of a Service Engineer (SE). During training program, travel to various U.S. service districts to work with a mentor or assist with SE related tasks. Upon successful completion of the training program, work as an SE in various service districts as needed for periods up to six months. Travel during the training period

1. Follow documented processes and procedures to determine consistently accurate and traceable assay values of commercial blood products used for daily QC and calibration by Sysmex customers. Establish and report such target values for QC materials according to production schedules. 2. Adhere to policies and procedures and maintain good laboratory practices. Document acti

1. Leads preparation, documentation and submission of FDA and Health Canada applications and providing responses to regulatory agencies regarding device information or issues. Includes the summary of data collected and demonstration of acceptable performance. Ensure understanding of risk and approximate timing for approvals for planning purposes 2. Manages maintenance of

1. Support document control system, including document implementation, coordination of SOP reviews, and archival. 2. Coordinate training and technologist competency assessments 3. Maintain on site employee files with periodic reviews and updates 4. Assist with quality review of internal documentation, such as equipment records, and testing records 5. Assist Quality Assura

1. System Administration and Validation (40%) Manages the talent management system through systems support, overseeing the day to day operations, and implementing processes related to system modules. Masters and maintains detailed knowledge of talent management product suite with an awareness of opportunities to expand solutions and services and performs the Superuser rol

1. Execute and implement R&D projects to meet objectives following timelines. 2. Conduct measurements; utilizing existing or new technologies, perform experiments and data analysis, mainly focusing on measurements. 3. Develop and evaluate novel assays; develop and evaluate novel assays to measure new analytes and reactions, primarily using in house measurement platforms.

Successfully complete all training to perform the duties of a Service Engineer (SE). During training program, travel to various U.S. service districts to work with a mentor or assist with SE related tasks. Upon successful completion of the training program, work as an SE in various service districts as needed for periods up to six months. Travel during the training period

Successfully complete all training to perform the duties of a Service Engineer (SE). During training program, travel to various U.S. service districts to work with a mentor or assist with SE related tasks. Upon successful completion of the training program, work as an SE in various service districts as needed for periods up to six months. Travel during the training period