Quality Assurance Engineer

Tosoh Bioscience, Inc.•Grove City, OH

5d•Onsite

About The Position

Tosoh Bioscience, Inc. (TBI), a U.S. subsidiary of Tosoh Corporation’s Bioscience Division, provides diagnostic systems to doctors’ offices, hospitals, and reference laboratories throughout the Americas. The Quality Assurance Engineer performs critical functions in support of TBI’s Quality System under the direction of the Quality Assurance Manager. The role supports compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, and Tosoh Bioscience quality policies and procedures. The engineer assists with implementation, management, and continuous improvement of the Quality System, and provides cross-functional engineering support to Operations, Facilities Control, and Manufacturing Project teams through system validations and data monitoring. The role includes equipment and instrument qualification, validation, calibration, maintenance, environmental monitoring, employee training, quality documentation, audits, and quality metrics.

Requirements

Associate’s or bachelor’s degree in a technical discipline, such as biomedical sciences, engineering, or a related field, and/or equivalent experience; the posting describes this education as preferred.
At least five years of relevant facilities and/or manufacturing IVD industry experience in an FDA-regulated or ISO 13485 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.
Ability to use tasking, scheduling, and other project management tools.
Ability to work independently and motivate others, and to relate effectively to both highly educated and unskilled team members across functional teams.
Ability to manage and resolve conflicts and work under stressful conditions.
Demonstrated ability or track record of successful results.
Attention to detail and timeliness.
Excellent verbal and written communication and interpersonal skills.
Ability to perform the essential duties satisfactorily, with reasonable accommodations as applicable.
Ability to work around moving mechanical parts, fumes or airborne particles, caustic chemicals, and risk of electrical shock; tasks may involve toxic chemicals and biohazards.

Nice To Haves

Training and experience using statistical analysis tools and developing test methods.

Responsibilities

Assist scientific staff in identifying and documenting requirements for new instruments, medical devices, and equipment to ensure they meet required specifications.
Generate Risk Management Assessment reports for equipment and engineering plans with subject-matter experts.
Prepare installation, operational, and performance qualification protocols; perform or direct protocol execution; and complete final validation reports.
Perform quality testing on devices to determine engineering tolerances and validation schemes.
Perform and document routine calibration and maintenance of applicable equipment.
Assist subject-matter experts in developing the TBI Master Validation Plan.
Write Quality System procedures for instrument operation, routine maintenance, and calibration.
Coordinate instrument maintenance and calibration performed by external vendors.
Manage the TBI environmental control monitoring system and coordinate responses and corrective and preventive actions for alarms and out-of-specification conditions.
Respond to equipment malfunctions and coordinate repairs performed by external vendors.
Train TBI employees on operating new laboratory equipment and responding to environmental monitoring system alarms.
Maintain detailed equipment records covering purchase, qualification, calibration, repair, and maintenance in accordance with Quality System procedures.
Assist with internal audits to assess TBI compliance with Quality System policies and procedures as needed.
Assist in developing and monitoring quality metrics.