Senior Software Quality Assurance Engineer

2 hours ago


Reston, Virginia, United States Bolt Medical Full time
Job Title: Senior Software Quality Assurance Engineer

Job Summary:

The Senior Software Quality Assurance Engineer will lead Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development projects and for automated data processing systems used as part of the quality system.

Key Responsibilities:

  • Lead design control and software development for medical devices, ensuring compliance with FDA and EU regulations.
  • Support risk management activities in line with ISO14971 and IEC 62304 standards.
  • Collaborate with various teams (software, hardware, UX, marketing, manufacturing, QA) to generate, document, verify, and validate requirements.
  • Support and optimize design control and software development processes.
  • Guide the creation, review, and approval of design control documents, focusing on software development.
  • Support software tools and computerized systems validation used in production and quality processes.
  • Participate in software development activities, including design and code reviews, requirements analysis, defect tracking, and configuration management.
  • Ensure compliance to IEC 62304, FDA, and EU Guidance on Software Contained in a 510(k) or EU MDR/IVDR submissions
  • Maintain effective risk management using feedback from various sources (validation, field service, post-market surveillance, etc.).
  • Support the creation and review of medical device software documentation, including cybersecurity assessments.
  • Ensure products comply with company procedures and global standards.
  • Support inspection and testing in design and manufacturing.
  • Assist with downstream processes like field service procedures and product returns.
  • Review Design History Files and Technical Files for compliance.
  • Support internal and supplier audits, NCR, and CAPA programs.
  • Perform other duties as assigned.

Requirements:

  • Bachelor's degree in Electrical, Computer/Software, or Biomedical Engineering.
  • Minimum of 7 years of experience in software quality engineering in a regulated environment.
  • Preferred: ASQ-CSQE certification.
  • Knowledge of FDA software guidance, ISO TR-80001, IEC 62304, and medical device standards.
  • Experience with software development lifecycle methodologies and new product development.
  • Strong analytical, problem-solving, and communication skills.
  • Ability to work in a team and manage priorities in a fast-paced environment.
  • Preferred: Knowledge of IEC 60601 medical device safety standards.

What We Offer:

  • Opportunity to work with a leading medical device company.
  • Collaborative and dynamic work environment.
  • Competitive salary and benefits package.
  • Professional development opportunities.


  • Reston, Virginia, United States Bolt Medical Full time

    Job Title: Senior Software Quality Assurance EngineerJob Summary:The Senior Software Quality Assurance Engineer will lead Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development projects and for automated data processing systems used as part of the quality system. The successful candidate...


  • Reston, Virginia, United States The Computer Merchant, LTD (TCM) Full time

    Job Title: Software Quality Assurance EngineerLocation: Sterling Heights, MDWage Range: $50-$60 per hour, depending on experience and qualificationsJob Description:We are seeking a skilled Software Quality Assurance Engineer to join our team at The Computer Merchant, LTD (TCM) in Sterling Heights, MD. As a Software Quality Assurance Engineer, you will be...


  • Reston, Virginia, United States RIT Solutions, Inc. Full time

    Job DescriptionWe are seeking a highly skilled Senior Quality Assurance Engineer to join our team at RIT Solutions, Inc. The ideal candidate will have a strong background in software quality assurance and test automation technologies.Key Responsibilities:Participate in the development and execution of automated tests using scripting languages such as Java...


  • Reston, Virginia, United States HCLTech Full time

    Job Title: Senior Quality Assurance Engineer LeadWe are seeking a highly skilled and experienced Senior Quality Assurance Engineer Lead to join our team at HCL Tech. As a key member of our Consulting and Solutions team, you will play a crucial role in delivering cutting-edge solutions in quality assurance and engineering areas.Key Responsibilities:Design and...


  • Reston, Virginia, United States Insight Global Full time

    Job Title: Software Quality Assurance EngineerJob Summary:We are seeking a highly skilled Software Quality Assurance Engineer to join our team at Insight Global. As a key member of our data collection and operation teams, you will serve as a liaison for the engineering team and work with our data engineering team to design engineering improvements to...


  • Reston, Virginia, United States Insight Global Full time

    Job Title: Software Quality Assurance EngineerJob Summary:We are seeking a highly skilled Software Quality Assurance Engineer to join our team at Insight Global. As a key member of our data collection and operation teams, you will serve as a liaison for the engineering team and work with our data engineering team to design engineering improvements to...


  • Reston, Virginia, United States EBizCharge Full time

    Job Title: Software Quality Assurance EngineerEBizCharge by Century Business Solutions is seeking a skilled Software Quality Assurance Engineer to join our team. As a QA Engineer, you will play a critical role in ensuring the highest level of quality control for our integrated payment solutions.Responsibilities:Develop and implement test plans, test cases,...


  • Reston, Virginia, United States Sustainable Talent Full time

    Join Our Team as a Software Quality Assurance EngineerSustainable Talent is seeking a highly skilled Software Quality Assurance Engineer to join our team. As a key member of our data collection and operation teams, you will play a crucial role in supporting Nvidia and their Engineering team.This is a W-2 full-time contract based in Santa Clara, CA. We offer...


  • Reston, Virginia, United States IRIS Software Group Full time

    Job Title: Senior Software Engineering DirectorWe are seeking a highly experienced Senior Software Engineering Director to lead our Americas software engineering function and resources. As a key member of the Americas Executive and Senior Leadership Teams, you will ensure that Engineering runs smoothly from conception and prioritization to scheduling and...


  • Reston, Virginia, United States ManpowerGroup Full time

    Job Title: Senior Quality Assurance EngineerJob Summary:We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at ManpowerGroup. The successful candidate will have a strong background in quality assurance and a proven track record of improving processes and driving efficiency.Key Responsibilities:Develop and implement quality...


  • Reston, Virginia, United States DNA Electronics (DNAe) Full time

    Software Quality Engineer Job DescriptionDNA Electronics (DNAe) is a pioneering company at the forefront of integrating cutting-edge sequencing technologies with innovative biochemical techniques to create a groundbreaking sample-to-answer sequencing platform. We are seeking an experienced Software Quality Engineer to join our team of professionals who are...


  • Reston, Virginia, United States IRIS Software Group Full time

    Job Title: Senior Software Engineering DirectorWe are seeking a highly experienced Senior Software Engineering Director to lead our Americas software engineering function and resources. As a key member of the Americas Executive and Senior Leadership Teams, you will ensure that Engineering runs smoothly from conception and prioritization to scheduling and...


  • Reston, Virginia, United States HCLTech Full time

    Job Title: Solution ArchitectJob Summary:HCLTech is seeking a highly skilled and motivated Solution Architect to join its team in advancing the technological world through innovation and creativity.Key Responsibilities:Enterprise Quality Engineering/Assurance Solutions:Develop comprehensive test strategies, frameworks, and methodologies to ensure the quality...


  • Reston, Virginia, United States Planet Technology Full time

    Job Title: Senior Quality Assurance EngineerWe are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Planet Technology. As a key member of our engineering team, you will be responsible for designing and executing tests for machine learning pipelines, ensuring the accuracy and reliability of our models.Key Responsibilities:Design...


  • Reston, Virginia, United States VIVA AI Full time

    About Viva AIViva AI is a pioneering company in the dental industry, leveraging advanced AI solutions to automate administrative tasks and empower dental professionals to focus on patient care. Our San Francisco-based startup is driven by a passionate and innovative team committed to revolutionizing the dental industry.Job SummaryWe are seeking a...


  • Reston, Virginia, United States Master Compliance Full time

    Job Title: Unit Test EngineerWe are seeking an experienced professional to join our team at Master Compliance as a Unit Test Engineer. This role is focused on the development and testing of Class III medical devices, requiring expertise in C++ and advanced unit testing tools such as VectorCAST and IBM Rhapsody Model Driven Development.Key...


  • Reston, Virginia, United States National Association of Boards of Pharmacy Full time

    This position is an excellent opportunity to join our team at the National Association of Boards of Pharmacy, offering a hybrid work model with two days a week at our Headquarters in Mount Prospect, IL.As a Senior QA Engineer, you will play a critical role in ensuring the quality of our software products through the design, development, and execution of...


  • Reston, Virginia, United States Software Technology Group Full time

    Job Title: Quality Assurance Automation EngineerWe are seeking a skilled Quality Assurance Automation Engineer to join our team at Software Technology Group. As a key member of our QA team, you will play a crucial role in ensuring the quality and reliability of our software products through the design, development, and execution of automated test scripts.Key...


  • Reston, Virginia, United States MS Shift, Inc. Full time

    At MS Shift, Inc., we are seeking a skilled Quality Assurance Engineer to join our team. The ideal candidate will have a strong understanding of software development lifecycle (SDLC) and QA methodologies, with a proven track record of delivering high-quality software products.Key Responsibilities:Test Planning and Design:Develop comprehensive test plans and...


  • Reston, Virginia, United States Austin Allen Company - Professional Recruitment Full time

    Senior Quality Engineer - AutomotiveJob Summary:Austin Allen Company - Professional Recruitment is seeking a highly skilled Senior Quality Engineer to join our client's team in the automotive industry. As a Senior Quality Engineer, you will be responsible for providing quality support to production operations, driving quality improvement, and ensuring the...