Jobs at Tosoh Bioscience, Inc.

The Quality Assurance Manager manages and improves the medical device quality system under FDA, ISO 13485, MDSAP, and ISO 14971 requirements. Responsibilities include internal, supplier, and third-party audits; CAPA and nonconformance investigations; root cause and risk analysis; quality metrics; document and change control; supplier quality agreements; and validation support. The manager leads direct reports, supports regulatory inspections, ensures record accuracy, develops employees, and provides cross-functional quality support.

Provide bilingual (Spanish/English) customer support by answering inquiries, entering orders into MAS500/Sage/Salesforce/EDI, processing returns and payments, maintaining customer records and regulatory documents (MSDS/Certificates of Analysis), generating reports, and coordinating with warehouse and suppliers.