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Handles medical device complaint investigations and regulatory compliance reporting for Tosoh Bioscience's in-vitro diagnostic systems — managing complaint tickets, determining reportability (FDA MDR, ISO, Health Canada, ANVISA), and supporting eMDR, CAPA, SCAR, recalls, and audits under 21 CFR 820 and ISO 13485.
Tosoh Bioscience, Inc., based in Grove City, Ohio 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…
Under the administrative direction of the Customer Operations Supervisor, the Operations Specialist provides support to Tosoh Bioscience, Inc.’s internal and external customers by coordinating the storage, handling,…
Quality Assurance Manager at Tosoh Bioscience (on-site in Grove City, OH) who manages the company's medical-device Quality System under FDA 21 CFR 820, ISO 13485, MDSAP and ISO 14971 — leading internal/supplier/third-party audits, CAPA and nonconformance records, quality metrics, and a team of direct reports.
A Quality Assurance Technician at a medical diagnostics manufacturer in Grove City, OH, maintains the Quality Management System by inspecting materials, running lab tests, managing GMP documentation and quality records, and supporting CAPAs, audits, and continuous improvement. Core work involves lab equipment operation, document control, and compliance with FDA/ISO 13485/cGMP standards.
An Associate Program Manager at Tosoh Bioscience splits their time 50/50 between leading cross-functional strategic projects and strengthening the PMO through portfolio-wide resource alignment, training, internal communication, and governance. Requires 3+ years of project leadership in a scientific or regulated environment, PMP or equivalent, and cGMP familiarity.
Tosoh Bioscience LLC is a major supplier of chromatography products to the pharmaceutical, biotechnology, and chemical industries. Our product line includes:TSKgel, TOYOPEARL, and Ca++Pure-HA bulk media, TSKgel U/HPLC…
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