Quality Assurance Manager – Audits & Compliance Leader

Tosoh; Grove City (OH); On-site; USD 85,000 - 120,000; Full time

Job summary

Tosoh Bioscience, Inc. is seeking a Quality Assurance Manager under the direction of the Senior Manager, Quality Systems and Compliance to support the company’s Quality System in line with FDA 21 CFR 820, ISO 13485:2016, MDSAP and ISO 14971.

The role leads cross functional engineering support to Operations, Facilities Control and Manufacturing Project teams through system validations and data monitoring, and will report to the Senior Manager with a team of direct reports.

Qualifications

• 8+ years in medical devices or healthcare quality or QA auditing.
• Experience managing direct reports is required.
• Proficiency with quality systems and CAPA processes.
• Familiarity with third party audits and regulatory inspections.

Responsibilities

• Lead internal and supplier audits, NC/CAPA, and quality agreements.
• Manage documentation control, change control and training.
• Review and report quality metrics monthly/quarterly.
• Support FDA and MDSAP audits as SME and coordinator.
• Direct cross-functional engineering support to operations.

Skills

Quality Management Systems

Auditing

CAPA & NC/CA

Quality Metrics

Office Applications

SmartSolve

Education

Bachelor's degree in science/engineering

Tools

SmartSolve

Job description

Tosoh Bioscience, Inc. is seeking a Quality Assurance Manager under the direction of the Senior Manager, Quality Systems and Compliance to support the company’s Quality System in line with FDA 21 CFR 820, ISO 13485:2016, MDSAP and ISO 14971.

The role leads cross functional engineering support to Operations, Facilities Control and Manufacturing Project teams through system validations and data monitoring, and will report to the Senior Manager with a team of direct reports.