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Medical Device Software Quality Engineer

Expired Job

Alku Indianapolis , IN 46201

Posted 3 months ago

Medical Device Software Quality Engineer


Our client is a large medical device company. They are in need of a Software Quality Engineer to provide expertise in Product Software Quality/Software as a Medical Device (SaMD) Design Controls.

Principle Duties and Responsibilities:

The Software Quality Engineer will be primarily responsible for implementing and maintaining Software Design History Files, and Software as a Medical Device (SaMD) Design Controls. This individual will be reviewing and approving software deliverables such as Change Records, Risk Files, Test Protocols and Problem Reports. The Software Quality Engineer should come from a Medical Device background, with experience in Software Quality, Design Controls, Software Development/SDLC (IEC 62304), 21 CFR Part 11, Risk Management (ISO 14971) and Usability/Human Factors Engineering (IEC 62366-1). Day-to-day activities/deliverables include:

Review and approve Problem Reports and Change Requests to resolve issues and implement enhancements.
Update Software DHF documentation to maintain compliance with 510k submission and CE marking.
Documents include but are not limited to: Software Requirements, Test Protocols and Reports, Risk Management files.
Review and approve Software DHF and Technical File documentation to achieve FDA 510k submission and CE marking.

Medical Device
Software Quality
Software as a Medical Device (SaMD)
Product Software Development
Design Control & Risk Management
IEC 62304 & IEC 62366-1
21 CFR 11 / ISO 14971 / ISO 13485
Bachelors Degree
MS Word, Excel, PowerPoint
Job Type: Contract

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Medical Device Software Quality Engineer

Expired Job