Atlanta, Georgia, United States · On-site
OXOS Medical, Inc. empowers every provider with the capability, clarity, and confidence to make accurate decisions at the point of care. We are building new kinds of radiographic imaging devices that push the boundaries …
Skills: Process Validation, ISO 13485, FDA 21 CFR 820, CAPA, FMEA
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The Manufacturing Quality Engineer ensures manufacturing processes comply with regulatory and internal quality standards for x-ray devices. Key duties include managing process validations, resolving nonconformances, and maintaining Device History Records.
Requires a Bachelor's degree in Engineering and at least 2 years of quality engineering experience in a regulated medical device environment. Proficiency in ISO 13485, 21 CFR 820, and process validation (IQ/OQ/PQ) is essential.
OXOS Medical, Inc. empowers every provider with the capability, clarity, and confidence to make accurate decisions at the point of care. We are building new kinds of radiographic imaging devices that push the boundaries of previous solutions by improving image quality, reducing radiation exposure, improving ease of use, and building solutions to deliver care outside of traditional scenarios. We enable anyone anywhere to access radiologic diagnostics at the point of need, expanding availability and changing how healthcare is delivered.
In-Person Position
The Manufacturing Quality Engineer is responsible for ensuring that manufacturing processes meet applicable regulatory and internal quality requirements. This role will be pivotal in scaling production of our cleared x-ray device, the MC2 Portable X-Ray System, managing process validations, supporting nonconformance resolution, and driving continuous improvement on the manufacturing line and within the quality management system.
This role is based in a hands-on production environment and will interface closely with manufacturing personnel. Our manufacturing facility is located in Midtown.
Shaping the future with safe, simple, and smart X-ray solutions.
Our mission is to make better healthcare accessible to everyone. Providers that use OXOS portable X-ray solutions are empowered with the confidence, clarity, and capability to make accurate decisions that improve the quality of care. Visit oxos.com to learn more.
Offices: 1100 Peachtree St NE, Suite 700, Atlanta, Georgia 30309, US
Shaping the future with safe, simple, and smart X-ray solutions.
Our mission is to make better healthcare accessible to everyone. Providers that use OXOS portable X-ray solutions are empowered with the confidence, clarity, and capability to make accurate decisions that improve the quality of care. Visit oxos.com to learn more.
Offices: 1100 Peachtree St NE, Suite 700, Atlanta, Georgia 30309, US
