Senior Software Quality Assurance Engineer
BioTalent · San Diego, California, United States
FULL TIMEpermanent
Job Description
Senior Software Quality Engineer San Diego, CA | Full-Time
For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on.
A fast-growing medical device company in San Diego is hiring a Senior Software Quality Engineer. This is their first dedicated software quality hire, an autonomous role building the function from the ground up. You’ll be the quality lead on software development for regulated devices, covering embedded, application and cloud-based systems.
What You’ll DoDevelop and maintain software quality assurance strategies, plans and procedures in line with FDA, ISO 13485 and IEC 62304Own software validation and traceability from requirements through code for product and non-product softwareLead quality review of test plans, test cases and automation scripts across unit, integration, system and regression testingLead defect management, including reviewing, dispositioning and verifying the resolution of software defectsParticipate in design reviews, code reviews and technical assessments to identify quality risks earlyPerform software risk analysis, develop mitigations and maintain software and system-level risk management filesPartner with cybersecurity and engineering teams on quality rigor for cloud and local data and patient-facing softwareDrive root cause analysis and CAPA for software defects, nonconforming product and customer complaintsConduct supplier audits and support internal and third-party audits as the software quality subject matter expertWrite and maintain SOPs, train cross-functional teams and drive continuous improvement in software quality processes, tools and metrics
What You’ll BringBachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering or a related field5+ years of experience in software quality assurance or software engineeringSoftware background, with the ability to read and understand codeHands-on software xzbcwsv validation experience, including experience developing software risk management filesWorking knowledge of cybersecurity fundamentalsUnderstanding of large-scale/cloud data vs. local data and patient-facing software interactionsWorking knowledge of FDA 21 CFR Part 820, ISO 13485 and IEC 62304Understanding of SDLC methodologies (Agile, Waterfall) in a regulated environmentCombined medical device and pharma/combination product experience is a plus
LogisticsBase salary: $170K–$180KLocation: San Diego, CA (onsite initially, hybrid flexibility once established)Travel: up to 10%
For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on.
A fast-growing medical device company in San Diego is hiring a Senior Software Quality Engineer. This is their first dedicated software quality hire, an autonomous role building the function from the ground up. You’ll be the quality lead on software development for regulated devices, covering embedded, application and cloud-based systems.
What You’ll DoDevelop and maintain software quality assurance strategies, plans and procedures in line with FDA, ISO 13485 and IEC 62304Own software validation and traceability from requirements through code for product and non-product softwareLead quality review of test plans, test cases and automation scripts across unit, integration, system and regression testingLead defect management, including reviewing, dispositioning and verifying the resolution of software defectsParticipate in design reviews, code reviews and technical assessments to identify quality risks earlyPerform software risk analysis, develop mitigations and maintain software and system-level risk management filesPartner with cybersecurity and engineering teams on quality rigor for cloud and local data and patient-facing softwareDrive root cause analysis and CAPA for software defects, nonconforming product and customer complaintsConduct supplier audits and support internal and third-party audits as the software quality subject matter expertWrite and maintain SOPs, train cross-functional teams and drive continuous improvement in software quality processes, tools and metrics
What You’ll BringBachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering or a related field5+ years of experience in software quality assurance or software engineeringSoftware background, with the ability to read and understand codeHands-on software xzbcwsv validation experience, including experience developing software risk management filesWorking knowledge of cybersecurity fundamentalsUnderstanding of large-scale/cloud data vs. local data and patient-facing software interactionsWorking knowledge of FDA 21 CFR Part 820, ISO 13485 and IEC 62304Understanding of SDLC methodologies (Agile, Waterfall) in a regulated environmentCombined medical device and pharma/combination product experience is a plus
LogisticsBase salary: $170K–$180KLocation: San Diego, CA (onsite initially, hybrid flexibility once established)Travel: up to 10%
Details
| Company | BioTalent |
| Location | San Diego, California, United States |
| Type | FULL TIME |
| Niche | healthcare |
| Experience | permanent |