Quality Assurance Engineer

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., based in South San Francisco, CA 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.SummaryUnder the direction of the Quality Assurance Manager, the Quality Assurance Engineer 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, ISO 14971, and Tosoh Bioscience Quality Policies and Procedures. The Quality Engineer assists in the implementation, management and continuous improvement of the TBI Quality System and provides cross-functional engineering support to Operations, Facilities Control and Manufacturing Project teams through system validations and data monitoring.Reporting RelationshipsThe Quality Assurance Engineer will report to the Quality Assurance Manager.Major Duties and ResponsibilitiesAssists scientific staff in identifying and documenting requirements for new instruments, medical devices, and equipment to ensure that each meets required specifications.Generates Risk Management Assessment reports for Equipment and Engineering Plans along with SME.Prepares protocols for installation, operational and performance qualification of instruments, performs and/or directs the execution of these protocols and completes the final validation reports.Performs quality testing on devices to determine engineering tolerances and validation schemes.Performs and documents all routine calibration and maintenance of applicable equipment.Assists in the development of the TBI Master Validation Plan with SME.Writes Quality System procedures for instrument operation, routine maintenance and calibration.Coordinates instrument maintenance and calibration performed by external vendors.Manages the TBI environmental control monitoring system, and coordinates responses and corrective actions and preventative actions to alarms and out-of-specification conditions.Responds to equipment malfunctions and coordinates repairs performed by external vendors.Trains TBI employees in the operation of new laboratory equipment and response to environmental monitoring system alarms.Maintains detailed equipment records on the purchase, qualification, calibration, repair and maintenance in compliance with documented Quality System procedures.Assists in internal audits to assess TBI compliance with Quality System policies and procedures as needed.Assists in the development and monitoring of quality metrics.EducationAn Associate's or Bachelor’s Degree is preferred in a technical discipline such as biomedical sciences engineering, engineering, or a related field and/or equivalent experience.Skills and QualificationsMinimum of five years of relevant facilities and/or manufacturing IVD industry experience in an FDA-regulated or ISO13485 environment with exposure to cGMP practices.Ability to understand Contract Manufacturing versus Manufacturer of Record quality and regulatory cGMP requirements for Facilities, Operations, and Manufacturing of Clinical Chemistry IVDD.Organizational, planning and detailed follow-up skills required. Ability to utilize tasking, scheduling, and other project management tools.Training and experience in the use of statistical analysis tools and test method development a plus.Ability to work independently and motivational talent required with ability to relate to both highly educated and unskilled team members effectively across functional teams within the organization.Ability to manage and resolve conflicts and work under stressful conditionsDemonstrated ability or track record of successful resultsAttention to detail and timeliness are critical.Excellent communication (verbal and written) and interpersonal skills required.Working ConditionsThe work environment characteristics described here are representative of those an employee encounters with performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Fumes, airborne particles, toxic chemicals are all potential elements of risk in performing job tasks related to servicing TBI analyzers/instruments. Although TBI provides all necessary equipment and training, there is an ever-present bio-hazard danger in the work environment.The job requires the employee to work under the following environmental conditions:Work near moving mechanical partsWork near fumes or airborne particlesWork near caustic chemicalsWork with risk of electrical shockNote: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required to be successful. Additional duties may be assigned in the future as required. Reasonable accommodations may be made for those individuals with disabilities in order to perform the essential functions.Tosoh Bioscience, Inc. is an Equal Opportunity Employer M/F/Disabled/Veterans