Quality Systems & Compliance Manager - Medical Devices

Tosoh Bioscience; Grove City (OH); On-site; USD 110,000 - 150,000; Full time

Job summary

Tosoh Bioscience, Inc. seeks a Quality Assurance Manager to support the Quality System in compliance with FDA 21 CFR 820, ISO 13485:2016, MDSAP, and ISO 14971.

You will lead cross-functional teams in system validations, data monitoring, and process improvements to ensure product quality and regulatory adherence. The role reports to the Senior Manager, Quality Systems and Compliance and leads a team of direct reports, contributing to continuous improvement and company branding.

Qualifications

• Bachelor’s degree in industrial technology, biology, chemistry, biochemistry, electrical/electronic/mechanical or bioengineering.
• Minimum 8 years’ experience in medical devices and healthcare product quality assurance, auditing, or QA.
• Experience managing direct reports; proficiency in Office applications; familiarity with regulatory audits and CAPA processes.

Responsibilities

• Conduct gap assessments against regulatory and company requirements.
• Lead internal and supplier audits, NC/CAPA, quality agreements; back-up for FDA and MDSAP audits.
• Manage review and reporting of quality metrics for QMS on a monthly/quarterly basis.
• Perform investigations and root cause analyses to determine risk levels and drive CAPA actions.
• Maintain accurate CAPA, non-conformance, and supplier records with references to Quality documents.

Education

Bachelor’s degree in relevant field

Tools

SmartSolve

Job description

Tosoh Bioscience, Inc. seeks a Quality Assurance Manager to support the Quality System in compliance with FDA 21 CFR 820, ISO 13485:2016, MDSAP, and ISO 14971.

You will lead cross-functional teams in system validations, data monitoring, and process improvements to ensure product quality and regulatory adherence. The role reports to the Senior Manager, Quality Systems and Compliance and leads a team of direct reports, contributing to continuous improvement and company branding.