Software Quality Engineer

Remote

Experience profile:

Ability to work independently, prioritize and meet deadlines, as well as handle multiple demands efficiently.

Knowledge of commonly used concepts, practices, and procedures within billing and customer care processes. Generally relies on instructions and pre-established guidelines to perform the functions of the position.

Strong written and oral communication skills.

Software Quality Management of Radiology device products to meet FDA design controls and other regulatory bodies

Software Quality Management of GxP relevant computer systems

You Will:

Software Quality Management of Software in Medical Device (SiMD) of Class-2 and Class-1 medical devices, including Application software, Embedded software, Platform software, Operating system software

Software Quality Management of Software as a Medical Device (SaMD) of Class-2 and Class-1 medical devices, including Application software, AI/ML software, Platform software including IaaS and PaaS, Cloud based software

Responsible for ensuring development initiatives of Radiology medical devices complies and adheres to regulatory standards and guidance such as FDA Design Controls CFR 820.30, IEC 62304 - Software in a Medical Device, IEC 82304 - Software as a Medical Device, IEC 14971 - Risk Management, ISO 13485 - Quality Management Systems, 2017/745 - European Union Medical Device Regulation (EU MDR) and various FDA guidance Pre-market submission guidelines, General Principles of Software Validation, Off The Shelf (OTS a.k.a SOUP) software use, Software as a Medical Device: Clinical Evaluation

Conducts evaluation of software engineering activities of medical device development including requirements, software risk analysis, design, development, documentation, integration, verification, validation and release to deliver medical devices that are safe, secure and effective

Reviews all the deliverables of medical device software lifecycle and provide clear, concise, and timely feedback to stakeholders

Responsible for ensuring computer system validation initiatives in Radiology organization complies and adheres to standards and guidance such as General Principles of Software Validation, Computer Software Assurance for Production and Quality System Software, FDA CFR Part 11 Compliance

Provides guidance to cross functional teams to ensure software quality objectives are met for medical device software development

Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function such as Software Problem Resolution meetings and documentation, CAPA actions, Process and template updates and Audit support

This role will:

This position will be responsible to perform software quality management activities of medical devices (Class-2) to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls and other regulatory bodies.

Qualifications:

Bachelors degree in Computer Engineering, Electronics, or Electrical Engineering

Minimum of 7 years of relevant work experience in software engineering or quality engineering in medical device development

Minimum of 2 years of relevant work experience in software quality management of Class 2 or Class 3 medical devices including Software in Medical Device (SiMD) or Software as Medical Device (SaMD)

Minimum of 2 years or more of experience in interpreting industry standards for medical device development and updating processes and procedures

Quality Management System - ISO 13485

SiMD - IEC 62304

SaMD - IEC 82304

FDA 21 CFR 820.30

2017/745 - European Union Medical Device Regulation (EU MDR)

Minimum of 2 years or more of experience in applying industry standards for medical device development as follows

General Principles of Software Validation

FDA CFR Part 11 Compliance

Must be able to handle multiple tasks/projects and manage priorities accordingly.

Technical writing ability - clear and concise writing easily understood by multiple audiences (auditors, peers, etc.

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Please send/Email resumes:

thoward@revolutiontechnologies.com