Quality Assurance Manager

About the role

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 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.

Under the direction of the Senior Manager, Quality Systems and Compliance, this position performs critical Tosoh Bioscience Inc. (TBI) functions in support of TBI’s Quality System in compliance with FDA Code of Federal Regulations (21 CFR 820), ISO 13485:2016, MDSAP, ISO 14971, and Tosoh Bioscience Quality Policies and Procedures. The Quality Manager assists in the implementation, management and continuous improvement of the TBI Quality System and leads and provides cross-functional engineering support to Operations, Facilities Control and Manufacturing Project teams through system validations and data monitoring.

Reporting Relationships

The Quality Assurance Manager will report to the Senior Manager, Quality Systems and Compliance. This position will have a team of direct reports.

Responsibilities

• Demonstrates an understanding of the regulatory and Company requirements and to perform gap assessments to those requirements.
• Medical Device Single Audit Program / MDSAP: Manage and/or support internal audits, supplier audits, NC/CAPA, quality agreements.
• Support Third Party Audits for FDA, and MDSAP as backroom coordinator and Subject Matter Expert.
• Review, establish, maintain, and report, monthly and quarterly, Quality metrics for the organization and QMS system.
• Perform investigations analysis independently including gap assessments and root cause analysis evaluations to determine risk level utilizing root cause analysis tools. Uses technical, scientific, and professional judgment for assessing the effectiveness of CAPAs and communicates to supervisor and area management when deficiencies are found.
• Ensures that CAPA, non-conformance, and supplier records are accurate, complete, and contain correct references to Quality documents, and/or processes such as Change Management, Audits, Non-Conformances, and Complaints.
• Critical Review of documents and document change requests. Experience in assessing the weight of evidence associated with a claim/hypothesis/assertion is preferred.
• Ensures the best level of service in compliance with reference rules and standards.
• Ensuring the level of scientific and technical skills necessary for the performance of your tasks.
• Contributes to business development and image/branding of the company.