Senior Software Quality Assurance Engineer

1 week ago


Carlsbad, United States Bolt Medical Full time
Job Title: Senior Software Quality Engineer

Bolt Medical is seeking a highly skilled Senior Software Quality Engineer to 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.
Preferred 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


  • Carlsbad, United States SIMS Software Full time

    About SIMS SoftwareSIMS Software is a pioneer in industrial security information management, providing innovative solutions and systems to the U.S. Government and defense contractors since 1983.Job DescriptionWe are seeking a Senior QA Engineer to join our QA team in Carlsbad, CA. As a key member of our team, you will play a critical role in ensuring the...


  • Carlsbad, United States SIMS Software Full time

    SIMS Software has been a pioneer in automating industrial security information management since 1983. We are the recognized industry leader in the field, providing the U.S. Government and defense contractors with innovative solutions and systems. Our clients include all branches of the military, many U.S. Government agencies, as well as most leading...


  • Carlsbad, United States SIMS Software Full time

    SIMS Software has been a pioneer in automating industrial security information management since 1983. We are the recognized industry leader in the field, providing the U.S. Government and defense contractors with innovative solutions and systems. Our clients include all branches of the military, many U.S. Government agencies, as well as most leading...


  • Carlsbad, United States Bolt Medical Full time

    Job DescriptionBolt Medical is seeking a highly skilled Senior Software Quality Assurance Engineer to lead our 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...


  • Carlsbad, United States Bolt Medical Full time

    DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.RECRUITERS: DO NOT CONTACT.Position overview: The Software Quality Engineer 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...


  • Carlsbad, United States Bolt Medical Full time

    DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.RECRUITERS: DO NOT CONTACT.Position overview: The Software Quality Engineer 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...


  • Carlsbad, United States Insight Global Full time

    Manual Software Test EngineerWe are seeking a skilled Manual Software Test Engineer to join our team in Carlsbad, CA. As a key member of our collaborative group, you will be responsible for performing manual testing and automation testing to ensure the quality of our proprietary software.Key Responsibilities:Perform manual testing to identify defects and...


  • Carlsbad, United States DNA Electronics (DNAe) Full time

    Job DescriptionWe are seeking a highly skilled Software Quality Engineer to join our team at DNA Electronics (DNAe). As a key member of our team, you will be responsible for ensuring that our software products meet the highest standards of quality and performance.ResponsibilitiesDevelop and implement quality assurance processes and procedures for software...


  • Carlsbad, United States Vuori, Inc. Full time

    Job DescriptionVuori, Inc. is seeking a highly skilled Senior Manager, Quality Assurance to lead our efforts in ensuring the quality and integrity of our enterprise solutions.This is a hands-on role that demands deep expertise in testing tools and automation software. As the Senior Manager, Quality Assurance, you will oversee testing for ERP, WMS, Wholesale...


  • Carlsbad, United States SCIEX Full time

    Job Title: Senior Manager, Quality AssuranceSCIEX, a leading provider of mass spectrometry and capillary electrophoresis solutions, is seeking a highly experienced Senior Manager of Quality Assurance to join our team. As a key member of our Quality Assurance & Regulatory Affairs (QARA) team, you will be responsible for developing and implementing quality...


  • Carlsbad, United States CDM Technology Full time

    Job DescriptionAs the Sr. Manager, Quality Assurance for Enterprise Solutions, you will lead efforts to ensure the quality and integrity of our enterprise solutions. This role demands deep expertise in testing tools and automation software. You will oversee testing for ERP, WMS, Wholesale Sales, EDI, and system integrations. Collaborating closely with...


  • Carlsbad, United States CDM Technology Full time

    Job DescriptionAs the Sr. Manager, Quality Assurance for Enterprise Solutions at CDM Technology, you will lead efforts to ensure the quality and integrity of our enterprise solutions. (Microsoft Dynamics 365 is a must)This hands-on role demands deep expertise in testing tools and automation software. You will oversee testing for ERP, WMS, Wholesale Sales,...


  • Carlsbad, United States CDM Technology Full time

    Hello, Our client is looking for a mature and experienced Senior Embedded Software Engineer. This is an immediate opportunity with an incredibly dynamic startup. Please inquire ASAP for this immediate opportunity.As a Software Engineer you will be expected to design, implement, debug and validate code for thermal system hardware. The thermal system is...


  • Carlsbad, United States DNA Electronics (DNAe) Full time

    DNAe, the inventors of semiconductor-based next-generation sequencing (NGS) technology, is developing a revolutionary new platform that enables NGS-based diagnostic capability in an easy to use, cartridge-based system that will allow direct from clinical specimen to clinically relevant, actionable results in a matter of hours.Job DescriptionWe are seeking a...


  • Carlsbad, United States DNA Electronics (DNAe) Full time

    DNAe, the inventors of semiconductor-based next-generation sequencing (NGS) technology, is developing a revolutionary new platform that enables NGS-based diagnostic capability in an easy to use, cartridge-based system that will allow direct from clinical specimen to clinically relevant, actionable results in a matter of hours.Job DescriptionWe are seeking a...


  • Carlsbad, United States CDM Technology Full time

    Job DescriptionAs the Sr. Manager, Quality Assurance for Enterprise Solutions, you will lead efforts to ensure the quality and integrity of our enterprise solutions. (Microsoft Dynamics 365 is a must!)This hands-on role demands deep expertise in testing tools and automation software. You will oversee testing for ERP, WMS, Wholesale Sales, EDI, and system...


  • Carlsbad, United States CDM Technology Full time

    Job DescriptionAs the Sr. Manager, Quality Assurance for Enterprise Solutions, you will lead efforts to ensure the quality and integrity of our enterprise solutions. (Microsoft Dynamics 365 is a must!)This hands-on role demands deep expertise in testing tools and automation software. You will oversee testing for ERP, WMS, Wholesale Sales, EDI, and system...


  • Carlsbad, United States Vuori, Inc. Full time

    Job DescriptionVuori, Inc. is seeking a highly skilled Senior Manager, Quality Assurance to lead our efforts in ensuring the quality and integrity of our enterprise solutions. As a key member of our team, you will be responsible for developing and implementing QA strategies, policies, and tools to ensure our applications consistently deliver quality and...


  • Carlsbad, United States CDM Technology Full time

    About the RoleCDM Technology is seeking a highly skilled Senior Embedded Software Engineer to join our team. As a key member of our Thermal Systems group, you will be responsible for designing, implementing, and validating software for complex thermal systems.Key ResponsibilitiesDesign and develop software for thermal system hardwareWork with...


  • Carlsbad, United States Insight Global Full time

    Manual Software Test EngineerWe are seeking a skilled Manual Software Test Engineer to join our team in Carlsbad, CA. As a key member of our collaborative group, you will be responsible for performing manual testing, automation testing, and participating in Agile meetings to ensure the highest quality software products.Key Responsibilities:Perform manual...