Jobs in the United States

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Added 1 min ago
Engineering Manager
American Woodmark
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5-10 years as an engineer in an industrial environment
Added 1 min ago
Mechanical Robotics Engineer
American Woodmark
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Added 1 min ago
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Added 1 min ago
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Senior Construction Contracts Project Manager
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Senior Systems Engineer
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Ground Command and Control Systems Engineer
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Coordinate quality assurance/quality control reviews and ensure deliverables meet client and project requirements.
Added 9 mins ago
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Added 11 mins ago
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Job Title: Engineer Field Senior or Engineer Lead
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- $125,000 USD / year
…throughout every element of a Slate, because people should have control over how their trucks look, feel, and represent…
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Quality Manager
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United States
Build skills and career paths (e.g., technician to engineer to senior roles) and a competency framework for the quality function.
Added 11 mins ago
Electrical Design Engineer, Senior
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Lead Full Stack Engineer, Wealth Management Technology
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Added 12 mins ago
SW Building Group Intern - Engineer
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…standard and custom connectors and APIs, following defined change control processes.• Monitor and manage ticket queues, provide technical support and guidance to makers and end users, and…
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Added 15 mins ago
Engineer- Manufacturing II USA (Thermal)
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Technician- Manufacturing Engineer I USA (Crew A)
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Ensure all processes are running on target as defined by the Process Control Plan
Added 15 mins ago
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Process Technician (Night Crew)
First Solar (US)
Trinity, AL
- $18.56 to $25.96 USD / hour
Respond to process control alarms through basic course correction and escalation through communication.
Added 15 mins ago
FS
Process Technician (Day Crew)
First Solar (US)
Trinity, AL
- $18.56 to $25.96 USD / hour
Respond to process control alarms through basic course correction and escalation through communication.
Added 15 mins ago
Electrical Service Technician (Engineer)
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Buffalo · Niagara Falls
…for the past ten years. The Electrical Service Technician (Engineer) will be a part of a rapidly growing Production team with opportunities to collaborate with various department’s…
Added 18 mins ago
AM
Senior AI Data Solutions Engineer
Air Methods
Greenwood Village, CO
- $137,000 USD / year
The Senior AI Data Solutions Engineer is responsible for designing, building, and deploying internal AI applications and data products within the Company’s Snowflake ecosystem. This role…

Tosoh Bioscience, Inc.

Quality Assurance Engineer

Grove City, OH, United States

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Job details

Posting language: English
Posted: Nov 4, 2026

Original 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.

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.

The job requires the employee to work under the following environmental conditions:

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/Veterans

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More about this job

Skills

Quality assurance
Medical devices
Risk management
Laboratory equipment
Regulatory compliance
Internal auditing
Biomedical science
Clinical biochemistry
Scheduling
Project management
Statistics
Work independently
Attention to detail
Communication skills
Interpersonal skills

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