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Added 2 mins ago
SB
Staff Firmware Engineer - AMR
Standard Bots
Boston, MA
- $180,000 to $215,000 USD / year
We're looking for an exceptional Staff Firmware Engineer to lead the firmware of Bolt's mobile base. This role sets the firmware architecture for that base from the first prototype: drive…
Added 2 mins ago
Sr. SDET
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Austin, TX
…and prevention capabilities. As a Senior Software Development Engineer in Test, you will help shape the quality strategy for a highly scalable, resilient platform by advancing automation,…
Added 2 mins ago
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ServiceNow
Remote, United States
It all started when engineer Fred Luddy wrote code that automated a tedious task for his coworker, Phyllis. She cried tears of joy. That moment inspired Fred to build a company that could…
Added 2 mins ago
Federal Sales Director - CRM Sales
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ML Engineer
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Information Security Consultant – Employee Experience Technology (EET)
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Professional certifications such as Security+, CISSP Associate, CISM, CRISC, Azure Security Engineer, or similar cybersecurity credentials.
Added 2 mins ago
Senior Security Engineer – ServiceNow SIR & DLP
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Senior Technology Delivery Lead will lead the end-to-end technology delivery of our enterprise ServiceNow Security Incident Response (SIR) and Data Loss Prevention (DLP) capabilities.
Added 3 mins ago
Packaging and Commercialization Specialist
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…outdoor moments–with great gear you can count on. That’s why we engineer high-quality products, like coolers, drinkware, and outdoor gear, that are overbuilt, not…
Added 4 mins ago
Senior Cyber Software Engineer
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Woburn, MA
The Defensive Cyber Technologies (DCT) group at STR is seeking a Senior Cyber Software Engineer to develop software and technical capabilities that improve the security and resiliency of…
Added 4 mins ago
Quality Engineer
nLIGHT
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Added 5 mins ago
Launch Readiness and Rehearsal Support_TS/SCI w/ poly
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Coordinate and ensure accurate integration of mission control operations documentation and test/launch operations with supporting agencies.
Added 5 mins ago
Interior Radar Development Support Engineer
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Our Interior Radar Development Support Engineer will execute the hands-on work of an in-cabin radar system: flashing, calibration, data collection, data quality, dataset preparation,…
Added 5 mins ago
A
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- $25 USD / hour
- Run scripted or programmatic data collection where the robot is driven by code rather than by hand.
Added 6 mins ago
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Experience with control algorithms using Matlab, Simulink or equivalent
Added 8 mins ago
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…unmatched capabilities of detection and sensing, command and control, and air-to-air, air-to-surface, and surface-to-air munitions to accomplish air, space and missile defense missions.…
Added 8 mins ago
Sr Space Simulation Analysis Engineering Systems Engineer
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…crossing all product areas such as sensors, effectors, command and control, logistics, and operations. They develop tools and methods to evaluate campaign, mission, and system level…
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…Assurance; Tools Development; Safety Analysis; Real-Time System Data Analysis; Problem Analysis; System…
Added 9 mins ago
Associate Software Engineer
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…Assurance; Tools Development; Safety Analysis; Real-Time System Data Analysis; Problem Analysis; System…
Added 9 mins ago
Site Reliability Engineer I
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The Service Operations Technology (SOT) BizOps team is seeking a Site Reliability Engineer (SRE) to support and enhance enterprise infrastructure, asset management, automation, and…
Added 10 mins ago
MC
Spacecraft Flight Dynamics Engineer
Motive Companies
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- $150,000 to $190,000 USD / year
We are seeking an experienced Spacecraft Flight Dynamics Engineer to join the flight program team. This role is highly hands-on and will support spacecraft from design and simulation…
Added 11 mins ago
Production Manager II
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Continuous Improvement: Analyze data, identify inefficiencies, and implement strategies to improve processes and productivity.
Added 11 mins ago
System Engineer Manager, Information Technology
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…from sluggish, siloed customer engagement efforts to agile, data-driven strategies that deliver unmatched efficiency and tangible…
Added 12 mins ago
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We are seeking a Data Engineer & Insights Analyst to transform complex data into trusted, usable information that supports program delivery, operational improvements, and executive…
Added 14 mins ago
NAMS2 - Software Engineer
Crown Innovations, Inc.
Mountain View, CA
Crown is looking for an experienced Software Engineer to work on the NAMS-2 project in Mountain View, CA to:

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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