Quality Assurance Engineer

Tosoh Bioscience; 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

Job Details: Job Location: Grove City OH - Grove City, OH 43123, Position Type: Full Time, Education Level: Associate's Degree, Travel Percentage: None, Job Shift: Standard Business Hours, Job Category: Biotech, 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.

Summary

Under 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 Relationships

The Quality Assurance Engineer will report to the Quality Assurance Manager.

Major Duties and Responsibilities

• Assists 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.

Education

An 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 Qualifications

• Minimum 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 conditions
• Demonstrated ability or track record of successful results
• Attention to detail and timeliness are critical.
• Excellent communication (verbal and written) and interpersonal skills required.

Working Conditions

The 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.

• Work near moving mechanical parts
• Work near fumes or airborne particles
• Work near caustic chemicals
• Work with risk of electrical shock

Note: 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/VeteransQualifications: