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Software Quality Assurance Manager

Kaliber is seeking a Manager of Software Quality Assurance with the expertise and desire to join a rapidly growing company with an ambitious vision to transform surgical care to the benefit of patients and surgeons. This position will be responsible for ensuring the artificial intelligence- enabled software solutions meet high quality standards and will have ownership over the quality processes supporting the design, development, and sustaining of Kaliber’s solutions for arthroscopic surgery. The ideal candidate is a self-starter who can both independently and collaboratively contribute to product requirements and technical engineering discussions.


  • Lead a team of SQA engineers and manage the verification of software as a medical device (SaMD)

  • Manage SQA engineers, lead, develop and support the team through mentoring and problem solving

  • Lead in the recruitment of SQA engineers - insource and outsource

  • Develop test strategies, provide guidance in the execution of testing campaigns for SaMD

  • Work in close collaboration with AI research, application development, test automation, QA/RA, technical project management, and product leads, to ensure system level software, hardware integration, human factor/usability, reliability, service and maintenance requirements and specifications is traceable and meet regulatory and quality standards (21CFR820, IEC 62304, 62366, 60601, ISO 14971, cybersecurity) and incorporate industry best practices

  • Participate in and/or lead risk assessment activities and work with design teams to develop effective risk control measures per ISO 14971, cybersecurity, and collateral standards

  • Lead and mentor staff to create product documentation, requirements, specification, user stories, and test cases

  • Lead and own project deliverables, set goals and assignments for the team, prioritize and oversee tasks

  • Allocate resources, manage projects and schedules

  • Analyze software requirements and design inputs, oversee team's development of test documentation deliverables that complies with ISO 13485 and IEC 62304 standards

  • Provide cross-functional support for the development of new product types and novel components, including preparation and maintenance of software development and configuration management plans, system design and architecture documents, etc., and more generally expected documentation in support of FDA submissions.

  • Monitor quality trends, contribute to process improvements, and collaborate with quality partners

  • Support software deployments in a variety of test, staging, and production environments

  • Participate in ongoing implementation of Software Development Life Cycle best practices and other Quality Management System processes in alignment with US FDA QSR and ISO 13485, in support of AI-powered products and SaMD initiatives

  • Provide CAPA, complaints, audit and overall QMS support in regards to software


  • Bachelor's degree in a technical discipline

  • 10 years of Software Quality Assurance experience, with part of this experience including
    SaMDs development and management best practices from feasibility through launch and
    sustaining phases in a regulated environment

  • 3 years managing teams

  • Technical domain knowledge of localization and internationalization quality assurance
    processes and methodologies

  • Experience implementing Quality Assurance best practices pertaining to requirements
    tracking, test definition, and test automation

  • Strong understanding of QA principles and processes in an FDA regulated environment

  • Excellent interpersonal, written, and verbal communication skills

  • Excellent analytical and problem-solving skills, finding creative solutions

  • Passion for quality and attention to detail

  • Previous experience testing medical devices and the related verification, validation, and
    documentation requirements

  • Experience working in Agile development environment with Atlassian tools

  • Hands-on experience in implementing test automation frameworks using Java or Python.

  • Experience with cucumber/BDD testing methodologies.

  • Experience with testing micro services in a distributed environment.

  • Exposure to AI models is a plus.

  • Demonstrated ability to implement and improve Software QMS processes using SDLC best practices, tools and agile/scrum/iterative methodology


Position is located at our Santa Clara, CA office.


  • Competitive compensation and stock options

  • Medical, dental, and vision insurance

  • Unlimited vacation

  • Opportunity to collaborate with world-renowned surgeons to help shape the future of surgery


Email resume and cover letter highlighting significant accomplishments to:

Kaliber's Values

Kaliber is proud to be an Equal Opportunity Employer. We are committed to equal employment
opportunities regardless of race, color, ancestry, religion, sex (including pregnancy), national
origin, sexual orientation, age (40 or older), citizenship, marital status, disability, gender identity,
genetic information, or Veteran status. We also consider qualified applicants regardless of
criminal histories, consistent with legal requirements.

About Kaliber Labs

Kaliber builds AI-powered solutions to meet the needs of patients, surgeons, and administrators
in orthopedic surgery. Our intelligent software is designed to generate insights from surgical
procedures—cut to close—and channel them into surgeon-centric tools to support quality,
access, and cost of care.

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