Quality Technician jobs in United States
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GT Medical Technologies, Inc. · 10 hours ago

Quality Technician

GT Medical Technologies, Inc. is seeking a Quality Assurance Technician I responsible for verifying the accuracy and compliance of Device History Record (DHR) data. The role includes performing inspections, managing documentation, and ensuring compliance with standards and regulations in a manufacturing environment.

Health CareMedicalMedical DeviceNeuroscienceTherapeutics

Responsibilities

Supports manufacturing of both product lines through the following:
Review incoming orders to assess compliance to applicable standards
Perform final product inspections and responsible for documenting product release activities
Summarizes data and coordinates with manufacturing supervisors the efficient/timely release of product
Follows detailed procedures documented in SOP's, work instructions, forms and on check lists
In-process testing of devices (post manufacturing, post sterilization, etc.)
Manages forms/manufacturing facility procedures in compliance with organizational guidelines
Ensure the manufacturing facility procedures comply with SOPs and applicable GMPs and ISO standards and comply with customer requirements
Maintain files/documentation ensuring these are easily retrievable
Ensure consistency/compliance of document structure and compliance with established SOPs, ISO standards and applicable cGMP
Adheres to the Company’s purpose operating principles, building a positive and productive team culture
Comply with Company policies and procedures and safety protocol
Authorized to access employee and/or patient PHI and ePHI only as needed for job-related functions
Training employees on the job duties associated with the Quality Assurance Technician I job role
Other duties as assigned

Qualification

21CFR Part 820ISO 13485 2016Quality Management SystemsMeasurement equipmentDocumentation skillsAnalytical skillsMicrosoft OfficeProblem-solving skillsTeam collaborationDetail-oriented

Required

Associate's degree in technical or business related field
Prior QA experience required
Ability to read, write and follow verbal and written instructions
Strong documentation and organizational skills
Ability to operate and communicate effectively with cross-functional teams
Strong analytical and problem-solving skills
Ability to multi-task and work within deadlines
Must be detail oriented with the ability to work both independently and as a part of a dynamic team
Ability to establish and maintain effective working relationships relevant with cross functional teams
Ability to read and interpret Standard Operating Procedures (SOPs) and work instructions
Ability to accurately collect and organize data
Must be able to perform basic mathematical functions using whole numbers, fractions, and decimals
Must be able to compute averages, rates, percent and to draw and interpret bar graphs
Excellent written and verbal communication skills
Proficient in using Microsoft office programs (Word, Excel, and PowerPoint)
Willingness to work a flexible schedule
Able to travel for work as needed
Satisfactorily pass comprehensive background screening

Preferred

Bachelor's degree preferred
1 year of experience in a radiation-controlled environment preferred
Working knowledge of 21CFR Part 820 and ISO 13485:2016 regulations and experience with Quality Management Systems preferred
Prior experience in clean room operations and environmental monitoring testing is preferred

Company

GT Medical Technologies, Inc.

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GT Medical Technologies was founded by a dedicated team of brain tumor specialists to address unmet needs in brain tumor treatment.

Funding

Current Stage
Late Stage
Total Funding
$162.52M
Key Investors
Evidity Health CapitalHorizon Technology FinanceGilde Healthcare
2025-01-16Series D· $53.3M
2024-09-12Debt Financing· $35M
2024-04-29Series Unknown· $0.22M

Leadership Team

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Brian Martin
Senior Vice President, Corporate Affairs & Investor Relations, Board Secretary
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Company data provided by crunchbase