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Senior Software Quality Engineer
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Senior Software Qual....
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Senior Software Quality Engineer

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1 Vacancy
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Jobs by Experience

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5+ years

Job Location

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Burlington - USA

Monthly Salary

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Not Disclosed

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Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Req ID : 1952427
Attention Software Quality Engineers! Are you ready to bring your A-game and take the medical device industry by storm? Do you have what it takes to ensure the quality of our software products for new medical devices? If so, then you need to hear about this incredible opportunity!

Were looking for a Senior Software Quality Engineer who is a true rockstar when it comes to software validation and testing. Youll work hand-in-hand with our Design team to develop and validate class II and III medical devices that meet and exceed regulatory industry standard requirements. If you have at least 5 years of Software quality experience and New Product Development experience for a software medical device, then we want to hear from you!

Responsibilities:
  • Own the companys Software Quality Assurance process including the software validation testing activity and associated documentation
  • Review and approve software product documentation (SRS, SDS)
  • Create and execute test cases to ensure the quality of our software products
  • Log and verify bugs and aid in associated root cause investigation and corrective action activity
  • Work closely with our development team to ensure the timely delivery of high-quality software products
  • Conduct performance, load, and stress testing and continuously break and test things to achieveto identify and resolve potential performance issues
  • Work closely with our design team to ensure that software products are in line with the desired specifications and user requirements
  • Develop and maintain testing documentation, including test plans, test cases, and test reports
Requirements:
  • At least 5 years of experience in software quality assurance for Class II and III medical devices
  • Software validation experience for a regulatory submission and completion of New Product Development (NPD) for a Class II and/or Class III medical device
  • Working knowledge of current regulatory industry standard requirements such as FDA 21 CFR Part 11& Part 820, ISO 13485:2016, and IEC 62304:2006 is required
  • Can own the QA process from start to finish
  • Linux experience is a plus
  • Bachelors degree in Computer Science, Engineering, or a related field
  • Fully vaccinated against COVID-19
Whats in it for you:
  • Competitive salary and benefits package
  • Hybrid work set-up
  • Your work will have an immediate impact on our products
  • You have the autonomy to decide your terms
  • Career growth
  • Youll get to enjoy all the benefits that come from being part of a small, growing, well-funded company


Bachelor s Degree in Computer Science or a related field preferred 4+ years of design and development of software and completing software validation for a medical device Medical devices industry experience is required Ability to own the QA process from start to finish Experience with Linux is a plus Comfortable working in both a fast-paced and startup environment

Employment Type

Full Time

About Company

0-50 employees
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