Senior Software Quality Assurance Engineer

3 weeks ago


Reston, Virginia, United States Bolt Medical Full time

Software Quality Engineer Role Overview:

The Software Quality Engineer at Bolt Medical is responsible for leading 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 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.
  • 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.

Key Skills:

  • Experience with medical device software development.
  • Experience in Non-Product Software Validation, IQ OQ PQ.
  • Experience with a risk-based approach to validate computerized systems.
  • Detail oriented and organized.
  • Skilled in written and verbal communication.
  • Highly responsive.
  • Ability to work in a team environment.
  • Highly motivated hands-on engineer with a proven record of meeting timelines and goals.
  • Must possess strong analytical & problem-solving skills.
  • Ability to manage priorities and meet deadlines in a fast-paced environment.
  • Must have strong analytical reasoning.
  • Must have problem-solving capabilities.
  • Self-driven individual who is capable and excited to learn about new technologies.


  • 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.Key Responsibilities:Lead...


  • Reston, Virginia, United States General Dynamics Information Technology Full time

    Job Title: Senior Software Quality Assurance EngineerJob Summary:General Dynamics Information Technology (GDIT) is seeking a highly motivated Senior Software Quality Assurance Engineer to join our team. As a Senior Software Quality Assurance Engineer, you will be responsible for developing software/systems testing procedures and conducting tests to ensure...


  • Reston, Virginia, United States TM Floyd & Company (TMF) Full time

    TM Floyd & Company (TMF) is seeking a Senior Software Quality Assurance Engineer to join our team in Columbia, SC.Key Responsibilities:Design and execute comprehensive testing strategies to ensure software quality and reliability.Collaborate with cross-functional teams to identify and prioritize testing objectives.Develop and maintain testing scripts and...


  • Reston, Virginia, United States TM Floyd & Company (TMF) Full time

    We are seeking a Senior Software Quality Assurance Engineer to join TM Floyd & Company (TMF) in Columbia, SC. This position offers a 50% remote work arrangement.Key Responsibilities:Design and execute test plans to ensure software qualityCollaborate with cross-functional teams to identify and prioritize testing needsDevelop and maintain test data and...


  • 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:NVIDIA's deep learning platform has made a significant impact in the field and is widely used across leading academic institutions, start-ups, and industry. We are seeking a skilled Software Quality Assurance Engineer to join our team and contribute to the development of state-of-the-art autonomous...


  • 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 American College of Radiology Full time

    Job SummaryAmerican College of Radiology (ACR) is a leading organization in the field of radiological care, representing nearly 40,000 medical specialists. We are seeking an experienced Senior Software Quality Assurance Lead to join our team and lead our Quality Assurance team in ensuring the quality, reliability, and performance of our software products.Key...


  • Reston, Virginia, United States Kreative Technologies Full time

    Job Summary:Kreative Technologies is seeking a skilled Software Quality Assurance Engineer to join our Agile team. As a key member of our development team, you will be responsible for ensuring the quality and functionality of our software applications.Key Responsibilities:Perform software testing, analysis, and assessment to identify defects and areas for...


  • 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 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 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 GeoLogics Corporation Full time

    Job Title: Senior Quality Assurance EngineerJob Summary:GeoLogics Corporation is seeking a Senior Quality Assurance Engineer to join our team. The successful candidate will be responsible for electrical/electronic assembly supplier quality interactions on a given set of programs. This includes investigating, evaluating, and resolving supplier quality...


  • Reston, Virginia, United States Lumicity Full time

    Lumicity is partnering with a pioneering IoT startup to revolutionize sustainable technology interactions.We are seeking a Quality Assurance Software Engineer to contribute to our team.Key Responsibilities:Test Automation: Develop and maintain automated test frameworks and scripts using Python to ensure hardware and software reliability and performance.Test...


  • Reston, Virginia, United States Omron Robotics and Safety Technologies Full time

    About Omron Robotics and Safety TechnologiesWe are a global leading provider of intelligent vision-guided robotics systems and services. Our mission is to develop social needs-driven solutions for the global automation market. Our robotics systems provide unmatched performance and economic value throughout the production lifecycle, enabling customers to...


  • Reston, Virginia, United States Redbock - an NES Fircroft company Full time

    Role Summary:We are seeking a Senior Quality Assurance Engineer to support new product development for various product families in the Surgical Innovations Business.Key Responsibilities:Develop and maintain quality standards and protocols for processing materials into partially finished or finished materials product.Collaborate with engineering and...