QA Engineer, IVD Medical Devices & Compliance

Tosoh-3; Grove City (OH); On-site; USD 80,000 - 115,000; Full time

Job summary

Tosoh Bioscience, Inc. in the United States seeks a Quality Assurance Engineer to support the Quality System in compliance with FDA 21 CFR 820, ISO 13485, and ISO 14971. You will assist in risk assessments, validations, calibrations, and cross-functional projects across Operations and Manufacturing.

The role emphasizes documentation, audits, and continuous improvement, with opportunities to train staff on instruments and monitoring systems in a fast-paced environment.

Qualifications

• Minimum five years of facilities/manufacturing IVD industry experience in FDA-regulated or ISO13485 environment.
• Understanding cGMP requirements for Facilities, Operations, and Manufacturing of Clinical Chemistry IVDD.
• Excellent planning, organizational and follow-up skills.
• Ability to work independently and with cross-functional teams.
• Strong written and verbal communication skills.

Responsibilities

• Identify and document requirements for new instruments and equipment to meet specifications.
• Generate Risk Management Assessment reports for Equipment and Engineering Plans with SMEs.
• Prepare IQ/OQ/PQ protocols and execute validations; finalize validation reports.
• Perform quality testing to determine tolerances and validation schemes.
• Calibrate and maintain applicable equipment; document activities.
• Develop Master Validation Plan with SME input.
• Write Quality System procedures for instrument operation, maintenance and calibration.
• Coordinate instrument maintenance/calibration with external vendors.
• Train employees on new laboratory equipment and alarm responses.
• Maintain detailed equipment records per Quality System procedures.
• Support internal audits and monitor quality metrics.
• Assist cross-functional teams in Operations, Facilities, and Manufacturing.

Skills

Quality Assurance

FDA compliance

ISO 13485

cGMP

Data monitoring

Risk management

Calibration

Documentation

Training

Project management

Statistical analysis tools

Education

Associate's Degree

Bachelor's Degree

Biomedical sciences

Engineering

Tools

Statistical analysis tools

Job description

Tosoh Bioscience, Inc. in the United States seeks a Quality Assurance Engineer to support the Quality System in compliance with FDA 21 CFR 820, ISO 13485, and ISO 14971. You will assist in risk assessments, validations, calibrations, and cross-functional projects across Operations and Manufacturing.

The role emphasizes documentation, audits, and continuous improvement, with opportunities to train staff on instruments and monitoring systems in a fast-paced environment.