Software Quality Engineer
Company: VirtualVocations
Location: Boca Raton
Posted on: September 15, 2023
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Job Description:
A company is looking for a Software Quality Engineer in the
field of Software Engineering.
Key Responsibilities:
Manage software quality of medical devices, including application
software, embedded software, platform software, and operating
system software
Ensure compliance with regulatory standards and guidance such as
FDA design controls, IEC standards, ISO standards, and EU Medical
Device Regulation
Evaluate software engineering activities throughout the development
process, including requirements analysis, design, integration,
verification, validation, and release
Remote Qualifications:
Bachelor's degree in Computer Engineering, Electronics, or
Electrical Engineering
Minimum of 7 years of relevant work experience in software or
quality engineering in medical device development
Minimum of 2 years of experience in software quality management of
Class 2 or Class 3 medical devices
Experience interpreting and applying industry standards for medical
device development, such as ISO 13485, IEC 62304, IEC 82304, FDA 21
CFR 820.30, and EU Medical Device Regulation
Experience with AI/ML based medical device software quality
management is preferred
Keywords: VirtualVocations, Boca Raton , Software Quality Engineer, IT / Software / Systems , Boca Raton, Florida
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here to apply!
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