Be an early applicantLess than 25 applicantsPosted by Agency
Intellectt Inc · 2 days ago
Senior Software Quality Engineer
Los Angeles, CA
Full-time
Onsite
Senior Level
7+ years exp
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Responsibilities
Provide guidance and training for Software Validation, Data Integrity, and Software Requirement Specification.
Collaborate with R&D and Manufacturing Engineering on system/software requirements and verification processes.
Participate in reviews for System and Software requirements, interpreting system design and providing feedback.
Create and execute software validation protocols traceable to system/software requirements.
Analyze test data using test equipment, administer Code Control and Software Event/Defect Tracking systems.
Assist in risk analysis, focusing on software-related risks including cybersecurity and data integrity.
Review and approve assessments to comply with FDA regulations.
Design and implement product and process improvement methodologies.
Apply problem-solving methodologies in identifying and resolving issues.
Support internal and external quality audits, comply with regulatory requirements, and maintain positive communications.
Support Company initiatives in alignment with Quality Management Systems and regulatory requirements.
Qualification
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Required
Bachelor’s Degree Engineering (Electrical/Computer Engineering preferred) or Technical Field OR an equivalent combination of education and work experience
Minimum 7 years of experience
Experience in firmware or embedded software testing and verification/validation
Software Quality Engineering experience
Cybersecurity and Data Integrity knowledge of SDLC
Programming experience in C/C++/C#, Scripting Language such as Python
Experience with software configuration, and issue-tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla
Detailed knowledge of FDA part 820, GMP, IEEE 1012, IEC 62304 and ISO 13485
Advanced computer skills, including statistical/data analysis and report writing skills
Advanced Information Technology and data mining skills
Prior medical device experience
ASQ CSQE certification desired
Preferred
Experience working with Bluetooth enabled systems and related software/firmware testing
Experience with unit- and integration-level testing and automated testing
Benefits
Health Insurance
Company
Intellectt Inc
Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry.
1,001-5,000 employees
H1B Sponsorship
Intellectt Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (231)
2022 (367)
2021 (259)
2020 (129)
Funding
Current Stage
Late StageCompany data provided by crunchbase
