Software Design Quality Engineer (Contract) - REMOTE
Software Design Quality Engineer (Contract) - REMOTE RESPONSIBILITIES Engaging in the continuous implementation of the Software Quality Management System (QMS), aligning with the requirements of US FDA Quality System Regulations and ISO 13485 Design Controls, while also incorporating SDLC processes and tool enhancements.
This involves integrating internal and external best practices from the medical device industry.
Providing guidance to software development teams on design controls and risk management activities.
Offering support to software development teams in the creation of comprehensive Design History Files (DHFs).
This includes the development of software development plans, software verification and validation plans, software requirements specifications, software architecture and design documentation, facilitation of design and code reviews, management of the software Risk Management File (RMF), formulation of test protocols and reports, and establishment of traceability matrices.
Cultivating a culture of adherence to the quality system throughout the organization, with a particular focus on ongoing training and education related to software QMS and the SDLC framework.
Contributing to Corrective and Preventive Action (CAPA) processes, addressing complaints, support audits, and provide overall QMS assistance in relation to software quality.
Ongoing software maintenance by supporting the team in FDA submission package.
Supporting multiple products (US and EU version of the product), will be supporting different global compliance standards and a 510k submission in the US.
QUALIFICATIONS Minimum 6 - 10
years of software quality engineering experience within the medical devices industry Expertise in Design Control and Risk Management Software as a Medical Device (SAMD) development / product support experience Design Assurance experience (design control, software dev lifecycle, risk management) Excellent communications Collaborator EDUCATIONBachelor degree in computer science, engineering, or related technical discipline Recommended Skills Auditing Code Review Communication Corrective And Preventive Action (Capa) Design Assurance Iso 13485 Estimated Salary: $20 to $28 per hour based on qualifications.
This involves integrating internal and external best practices from the medical device industry.
Providing guidance to software development teams on design controls and risk management activities.
Offering support to software development teams in the creation of comprehensive Design History Files (DHFs).
This includes the development of software development plans, software verification and validation plans, software requirements specifications, software architecture and design documentation, facilitation of design and code reviews, management of the software Risk Management File (RMF), formulation of test protocols and reports, and establishment of traceability matrices.
Cultivating a culture of adherence to the quality system throughout the organization, with a particular focus on ongoing training and education related to software QMS and the SDLC framework.
Contributing to Corrective and Preventive Action (CAPA) processes, addressing complaints, support audits, and provide overall QMS assistance in relation to software quality.
Ongoing software maintenance by supporting the team in FDA submission package.
Supporting multiple products (US and EU version of the product), will be supporting different global compliance standards and a 510k submission in the US.
QUALIFICATIONS Minimum 6 - 10
years of software quality engineering experience within the medical devices industry Expertise in Design Control and Risk Management Software as a Medical Device (SAMD) development / product support experience Design Assurance experience (design control, software dev lifecycle, risk management) Excellent communications Collaborator EDUCATIONBachelor degree in computer science, engineering, or related technical discipline Recommended Skills Auditing Code Review Communication Corrective And Preventive Action (Capa) Design Assurance Iso 13485 Estimated Salary: $20 to $28 per hour based on qualifications.
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