Software Quality Engineer III @ Pharmavise Corporation | Jobright.ai
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Software Quality Engineer III jobs in Santa Clarita, CA
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Pharmavise Corporation ยท 4 days ago

Software Quality Engineer III

positionSanta Clarita, CA
timeContract
remoteHybrid
senioritySenior Level
date5+ years exp

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Food and BeverageHealth Care
Hiring Manager
Ricardo Joseph
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Responsibilities

Actively working within a team of Product Software Quality Assurance Engineers.
Actively contributing to all aspects of Software/Firmware Quality Assurance activities in a highly regulated Active Implantable Medical Device environment.
Ensuring the quality of software systems, validating product software and firmware requirements, security requirements, and compliances.
Overseeing design, development, and test of software related to all Clientโ€™s Neuromodulation product lines during their entire development life cycle, from requirements gathering phase to the retirement phase.
Creating and executing Design Validation Plan, Protocols, and Reports to perform System level testing of Neuromodulation products and report any issues discovered.
Performing review of design, development, and testing of software and firmware used in Clientโ€™s Neuromodulation product lines.
Performing review and approval of documentation associated with user requirements, hazard analysis, security risk assessment, usability, functional and design specifications, design reviews, test protocols, requirements traceability, etc.
Actively working to support Automated Test Equipment validation activities.
Validation activities, which encompass reviews of User Needs Requirements, Design Requirements, Functional, Architectural, Module Design Details, Code and Design reviews, Unit tests, Integration tests, System level (black box), Structural (white box), Test Automation, Ad-Hoc/Exploratory test activities, Cybersecurity, Usability, and Risk Management, Design FMEAs, and Hazard Analysis.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Software TestingTesting MethodologiesManual TestingDocumentationSoftware Development Life CycleIEC 62304Programming LanguagesC#C++SwiftNode.jsJavaJavaScriptWindowsIOSAndroidPythonLabViewMS degree in Computer ScienceMS degree in Software EngineeringMS degree in Electrical EngineeringNeuromodulation principlesCAPA experienceComplaint Handling experienceExternal Audit experienceRisk Management knowledgeISO 14971Premarket Cybersecurity GuidancePost Market Cybersecurity GuidanceBluetooth technology

Required

BS degree in Computer Science or Software/Electrical Engineering
5-8 years with BS degree, 3-6 years with MS degree, 0-3 years with PhD
Minimum of 3 years of Software testing in commercial products
Working knowledge of testing process and methodologies
Manual testing and documentation experience in a regulated environment
Understanding of Software Development Life Cycle Processes per IEC 62304
Some experience in Programming Languages such as C#, C++, Swift, Node.js, Java/JavaScript, Cloud, Windows, iOS, Android, Python, LabView

Preferred

MS degree in Computer Science or Software/Electrical Engineering
Must possess excellent organizational, clear verbal and written communication skills
Must be team-oriented with people skills and positive can-do attitude in dealing with a large number of customers, and several competing tasks from various departments (R&D, Marketing, Manufacturing, Quality and Regulatory, Clinical, Project Management, etc.)
Must be detail oriented and have a passion to โ€œBuild Quality Inโ€ the products
Experience working in the medical device industry or other highly regulated environment
Basic academic knowledge of principles of Neuromodulation
Experience with CAPA, Complaint Handling and External Audit
Experience/Understanding of Risk Management as per ISO 14971
Understand Premarket Cybersecurity Guidance, Post Market Cybersecurity Guidance and 81001-5-1
Understand Bluetooth technology
Understand Mobile applications development
Understand aspects of HIPAA and GDPR compliance practices
ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE)

Company

Pharmavise Corporation

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โ™ฆ๐„๐ฑ๐œ๐ž๐ฅ๐ฅ๐ž๐ง๐œ๐ž ๐ญ๐ก๐ซ๐จ๐ฎ๐ ๐ก ๐๐ฎ๐š๐ฅ๐ข๐ญ๐ฒโ™ฆ: ๐๐ก๐š๐ซ๐ฆ๐š๐ฏ๐ข๐ฌ๐ž, ๐ฒ๐จ๐ฎ๐ซ ๐ฌ๐ญ๐ซ๐š๐ญ๐ž๐ ๐ข๐œ ๐‹๐ข๐Ÿ๐ž ๐’๐œ๐ข๐ž๐ง๐œ๐ž๐ฌ, ๐‡๐ž๐š๐ฅ๐ญ๐ก๐œ๐š๐ซ๐ž ๐š๐ง๐ ๐†๐จ๐ฏ๐ž๐ซ๐ง๐ฆ๐ž๐ง๐ญ ๐ฌ๐จ๐ฅ๐ฎ๐ญ๐ข๐จ๐ง๐ฌ ๐ฉ๐š๐ซ๐ญ๐ง๐ž๐ซ.
dateFounded in 2013
location
Coral Springs, Florida, USA
people-size11-50 employees
web-link
http://www.pharmavise.com

Funding

Current Stage
Early Stage
Total Funding
unknown
2020-04-04Seedยท Undisclosed

Leadership Team

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Ricardo Joseph
Founder and CEO
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