200+ applicants
TMC · 2 days ago
Software Quality Engineer
San Francisco, CA
Full-time
Onsite
Entry, Mid Level
2+ years exp
Wonder how qualified you are to the job?
Maximize your interview chancesManagement ConsultingNanotechnology
Insider Connection @TMC
Responsibilities
Collaborate with product development teams, including software, system, test, and senior software quality engineers, to develop new software releases.
Provide quality oversight and recommendations to improve product design quality.
Support Design and Use/Mis-Use Failure Mode and Effects Analysis.
Perform software defect disposition.
Investigate and review customer complaints, ensuring thorough root cause investigations.
Conduct software-related Corrective and Preventive Actions (CAPA) root cause analysis and investigations.
Ensure product quality and reliability, ensuring medical devices' safety, effectiveness, and regulatory compliance.
Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures.
Evaluate software systems activities, including requirements, design, development, documentation, integration, test, verification, and validation.
Ensure projects and process control documentation comply with requirements, objectives, and/or contracts.
Provide quality representation during software issue disposition forums.
Support internal and external audits by regulatory agencies as needed.
Regularly interact with computers, peers, and co-workers while performing duties independently.
Qualification
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Required
Bachelor’s Degree in Engineering, Science, or a technical field with 2 years of experience in Engineering and/or Quality OR an Advanced Degree in Engineering, Science, or a technical field.
Preferred
Versatility, flexibility, and a willingness to work within constantly changing priorities.
Strong verbal and written communication skills; ability to present issues, plans, and objectives clearly.
Excellent organizational, problem-solving, and analytical skills.
Proficiency with Python, Java, JavaScript, Selenium, or C#.
Working knowledge of IEC 62304, FDA’s General Principles of Software Validation, ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, and MDD/MDR.
ASQ certification as a Software Quality Engineer.
Benefits
One-on-one coaching
Trainings for entrepreneurial skills
Networking opportunities
Company
TMC
TMC is a consultancy firm that provides companies with knowledge in the fields of physics, software, nanotechnology, and data science.
1,001-5,000 employees
H1B Sponsorship
TMC 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
2022 (2)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Morgan Guffroy
CEO
Company data provided by crunchbase
