GT Medical Technologies, Inc. · 15 hours ago
Quality Engineer II
Richland,WA,US
Full-time
Hybrid
Mid Level
3+ years expGT Medical Technologies, Inc. is focused on improving patient care through innovative medical device quality solutions. The Quality Engineer II is responsible for developing and implementing quality requirements, leading risk management activities, and providing technical support for process verification and validation activities.
Health CareMedicalMedical DeviceNeuroscienceTherapeutics
Responsibilities
Collaborate with cross-functional team (including Supply Chain, Manufacturing, Suppliers, Regulatory, etc.) to communicate, understand and solve quality problems
Evaluate product quality risks and acceptability of nonconforming materials
Develops, maintains and evaluates risk management file including supporting FMEAs
Provides investigative support for product quality issues
Utilize root cause analysis techniques to identify potential solutions to address those root causes within the corrective and preventive action system
Drive continuous improvements through observation, measurement and root cause analysis
Perform statistical analysis in support of root cause analysis, process control, and verification and validation activities
Develop new processes which support speed, cost reductions and quality improvements
Develop process validation requirements (IQ, OQ, PQ) and equipment qualifications
Manage the selection, qualification, and certification of responsible suppliers to provide materials that meet specifications for production requirements
Maintain supplier relationships that encourage technical input and contributions, as requested, concerning new products, processes, ideas, and improvements. Initiate actions required to maintain the supplier performance at high level
Adheres to the Company’s purpose operating principles, building a positive and productive team culture
Comply with Company policies and procedures
Authorized to access employee and/or patient PHI and ePHI only as needed for job-related functions
Other duties as assigned
Qualification
Required
BS in Engineering from an accredited college or university or relevant education and experience
Minimum of 3 years of experience in an engineering role in the medical device industry
Experience with business process development
Working knowledge in statistical analysis techniques
Experience in test method strategies, development and validation including GR&R
Experience with risk management methodology and experience with ISO 14971 or equivalent
Experience with FDA QSR 21 CFR Part 820 and ISO 13485 or equivalent
Ability to create and manage key internal and external partnerships
High level of attention to detail
Ability to demonstrate proficiency in issue resolution
Ability to manage multiple priorities with little direction
Familiar with product safety standards
Demonstrated Project Management skills
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
Lean Six Sigma Certification
Company
GT Medical Technologies, Inc.
GT Medical Technologies was founded by a dedicated team of brain tumor specialists to address unmet needs in brain tumor treatment.
51-200 employees
Funding
Current Stage
Late StageTotal Funding
$162.52MKey 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
Brian Martin
Senior Vice President, Corporate Affairs & Investor Relations, Board Secretary
Recent News
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