Quality Assurance Engineer – Medical Devices Validation

Tosoh Bioscience, Inc.; Grove City (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Tosoh Bioscience, Inc. in Grove City, OH is seeking a Quality Assurance Engineer to uphold the company's Quality System in line with 21 CFR 820, ISO 13485, and Tosoh Quality Policies. You will collaborate with Operations, Facilities, and Manufacturing to validate systems and monitor data.

Reporting to the QA Manager, you will develop validation protocols, perform instrument qualifications, manage environmental monitoring, and drive continuous improvement across the testing network.

Qualifications

• Five years of relevant facilities and/or manufacturing IVD industry experience in FDA-regulated or ISO13485 environment with exposure to cGMP.
• Understanding of Contract Manufacturing vs Manufacturer of Record quality and regulatory cGMP requirements.
• Strong organizational, planning and detailed follow-up skills; proficient with scheduling and project tools.
• Experience with statistical analysis tools and test method development is a plus.
• Ability to work independently and collaborate across functional teams.
• Attention to detail and timeliness are critical.
• Excellent written and verbal communication.

Responsibilities

• Assist scientific staff in identifying requirements for new instruments and equipment to meet specifications.
• Generate Risk Management Assessment reports for Equipment and Engineering Plans with SME.
• Prepare and execute installation, operational and performance qualification protocols and final validation reports.
• Perform quality testing to determine tolerances and validation schemes.
• Calibrate and maintain applicable equipment; document activities.
• Develop and monitor the Master Validation Plan with SME input.
• Write Quality System procedures for operation, maintenance and calibration.
• Coordinate instrument maintenance and calibration with external vendors.
• Manage environmental control monitoring system and respond to alarms and out-of-spec conditions.
• Coordinate repairs with external vendors and train employees on new equipment.
• Maintain detailed equipment records for purchases, qualification, calibration, and maintenance.
• Assist in internal audits and quality metric monitoring.

Skills

IVD industry experience

FDA-regulated compliance

ISO13485 knowledge

Quality system knowledge

Detail oriented

Project management basics

Statistical analysis basics

Education

Associate's/Bachelor's in biomedical sciences/engineering

Tools

Calibration protocols

Risk management

Environmental monitoring systems

Job description

Tosoh Bioscience, Inc. in Grove City, OH is seeking a Quality Assurance Engineer to uphold the company's Quality System in line with 21 CFR 820, ISO 13485, and Tosoh Quality Policies. You will collaborate with Operations, Facilities, and Manufacturing to validate systems and monitor data.

Reporting to the QA Manager, you will develop validation protocols, perform instrument qualifications, manage environmental monitoring, and drive continuous improvement across the testing network.