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.
Responsibilities:
- 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 Bayer 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 Bayer 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
- Bachelor’s 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
o Quality Management System – ISO 13485
o SiMD – IEC 62304
o SaMD – IEC 82304
o FDA 21 CFR 820.30
o 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
o General Principles of Software Validation
o FDA CFR Part 11 Compliance - Must be able to handle multiple tasks/projects and manage priorities accordingly.
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Contract
4 Sep 2023
Perth, Western Australia, Australia
Senior Site Planner - FIFO
Airswift are a Global Manpower Provider specializing in the Energy, ...
Airswift are a Global Manpower Provider specializing in the Energy, Infrastructure & IT sectors. Present in more than 70 countries around the world, our reach, and capabilities in the markets we service is unparalleled in the industry.
Senior Site Planner
Within Western Australia our Mining & Resources Division delivers engineering and construction projects for our key Tier 1 iron ore producing clients, which enables them to sustain and expand their mining operations throughout the Pilbara Region of Western Australia. As a trusted partner to the WA resource sector, our client is integrated in their Client’s Major Projects which enables them to go above and beyond and succeed together with their clients.
The Role:
This FIFO position will be an initial 12 month contract, with chance of extension, offered on an 8:6 roster from Perth. You will have the opportunity to work on an iconic WA project, gaining valuable experience in mine closure.- Interface with the client and contractors on site to understand long term maintenance plans, schedules and deadlines
- Provide reports & analysis to assist in the review and improvement of maintenance tasks and strategy
- Identification of risks and cost reductions opportunities and continuous improvement.
- Produce estimates in line with scope of works and schedule in line with the goals set by the construction manager
- Advise, assist and support Extension of Time Claim delay analysis as requested by the Project Management teams
We’re on the lookout for likeminded individuals who are passionate about finding solutions to wicked environmentally, social, and economic issues associated with Mine Closures.- Extensive experience working on major resource projects that include bulk earthworks
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- Effective planning ability, time management, and prioritisation
- Intermediate – advanced working knowledge of Primavera P6
- Accurate ability to forecast project schedules for staff, potential delays and completion dates
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Airswift has an exciting opportunity available for a Long-Term Large Project Construction Scheduler located in Houston, TX. About you You will act as a technical resource for Project Controls within the Global Project Methodology (GPM) work process. Supports the establishment of the overall schedule baseline and reporting to monitor and control the project within established tolerances of the baseline supporting efficient project execution. Coordinates data inputs from the various contractors and functions to ensure accurate forecasts and reporting of construction scope of work. Engages with the project steering team to understand causes of the deviation and the need to establish actions to mitigate, where deviations from established tolerances occur. Requires in-depth conceptual and practical knowledge in project controls, construction, and basic knowledge of related job disciplines. Also, you can complete each of the following tasks: Required qualifications\n\t
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Responsibilities:\n\n Qualifications:\n\n \n\n Additional Qualifications:\n\n Airswift has been tasked by one of its major clients to look for a Sr. Process Engineer to work in Deer Park, TX.
Responsibilities: Qualifications:
Additional Qualifications:\n\t
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