Software Quality Engineer
ICONMA
Job ID: 4017611162
Location: San Bruno, CA
Description:
**Overall Responsibilities:**
As a Software Quality Engineer at client, you will work with the software organization to act as a champion of Quality Assurance and Engineering activities throughout the software development lifecycle.
You hold your work and teams to the highest quality standards and ensure that all corporate business requirements, regulations, and other standards are met, as applicable.
This is a hands-on role where you will apply intensive, self-directed and diversified knowledge of engineering and quality principles for client’s software and platforms.
This contract position offers an opportunity to contribute to the enhancement and maintenance of digital health solutions that directly impact patient care and well-being.
**Top 3 Daily Responsibilities:**
Participate in ongoing implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, as well as SDLC processes and tool initiatives, through the integration of internal and external/medical device industry best practices.
Support software development teams in the creation of Design History Files (DHFs) including software development plans, software verification and validation plans, software requirements specifications, software architecture and design documents, design and code reviews, software Risk Management File (RMF), test protocols and reports and traceability matrices.
Support integration of ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC processes.
Guide software development teams in design controls and risk management activities.
Foster organizational compliance to the quality system including ongoing training and education on software QMS and SDLC framework. Provide CAPA, complaints, audit and overall QMS support in regards to software.
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
Remote: False
Min Salary: 0
Max Salary: 0
Salary Frequency: yearly
Posted Date:
URL: https://www.linkedin.com/jobs/view/4017611162
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