Role Description Under the direction of the Technical Support Manager, provides technical support services for Tosoh Bioscience, Inc. (TBI) customers, employees and applicable distributors with respect to TBI product lines and services and supports Complaints Handling and Compliance Reporting support in compliance with FDA Code of Federal Regulations (21 CFR 820), ISO 13485, and Tosoh Bioscience, Inc. (TBI) Policies and Procedures. Major Duties and Responsibilities - Provide exemplary technical phone support for customers, distributors (including Canada and Latin America) and TBI employees to resolve performance discrepancies of both reagents and instruments in accordance with the approved product specifications. - Routinely check the Technical Support voice mailbox/incoming requests (faxes & e-mails) and return customer calls and assume after hours on-call as assigned (from home office). - Make follow up phone calls/investigations to assure complete resolution of customer concerns. - Accurate entry of all customer calls into CRM software (Salesforce). - Identify potentially critical customer situations and provide meaningful data input to assist TSS group, complaints handling, and customer communications. - Document customer issues completely and accurately with effective communication to relevant departments/groups. - Comply with TBI Quality Management System, Quality Manual, Quality Policy and Mission Statement. - Maintain technical information in accordance with the TBI Quality System and Complaint Handling procedures. - Provide direct support to Complaints Handling and Compliance Reporting (e.g. MDR, Customer Notification) by annotating tickets and files in close collaboration with regulatory affairs and complaints staff, TSS, and all other applicable TBI staff. - Develop in-depth knowledge of all Tosoh reagent and instrument products as well as participate in ongoing scheduled training with TBI Subject Matter Experts. - Support new products, product updates and comply with Quality System documentation. - Participate in Technical Support projects as needed, including training of new employees. - Support other duties as assigned through Technical Support management. Qualifications - BS in medical technology or related biological field with a minimum of one (1) year experience in immunodiagnostics industry. - Prior technical service and customer support experience with excellent communications and interpersonal skills. - Must be polite, professional, courteous, particularly over the telephone. - Must show initiative, be a team player and be able to work independently. - Ability to work in a fast-paced environment with varied customer types, manage customer expectations and ensure customer satisfaction. - Possess strong problem solving as well as professional software application and computer skills to identify, research and resolve problems. - Maintains regular and reliable attendance. - Upholds and adheres to the Tosoh Bioscience, Inc. culture and guiding principles. Travel - Minimal (5-15%) Physical and Environmental Demands To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required to be successful. Additional duties may be assigned in the future as required. Reasonable accommodations may be made for those individuals with disabilities in order to perform the essential functions. Company Description Tosoh Bioscience, Inc., based in South San Francisco, CA is a U.S. subsidiary of Tosoh Corporation's Bioscience Division, headquartered in Tokyo, Japan. Established in the United States in 1989, Tosoh Bioscience has become known throughout the Americas for providing sophisticated diagnostic systems to doctor's offices, hospitals and reference laboratories. Tosoh remains at the forefront with a world class network of research facilities, scientists, engineers and customer support specialists.