Senior / Principal Software Quality Assurance Engineer

2 weeks ago

Oklahoma City, United States Fractyl Health, Inc Full time

Reports to: Senior Manager, Quality Assurance Engineering Position Summary Fractyl Health is seeking a highly skilled and experienced Senior/Principal Software Quality Assurance Engineer to join our team. The Senior/Principal QA Engineer will play a critical role in ensuring the quality and reliability of our software products, which are integral components of our medical devices. This individual will collaborate closely with cross-functional teams to develop and execute comprehensive testing strategies, maintain regulatory compliance, and drive continuous improvement in our software development processes. This role is expected to be a leadership role; the individual will have autonomy and provide mentorship and guidance to junior team members as well as external contractors.

Primary Responsibilities

Develop and implement comprehensive software test plans, test cases, and test scripts based on product requirements and design specifications.

Participate/consult in requirements definition process.

Lead software verification strategy and planning, and author verification and validation plans.

Conduct functional, regression, integration, and performance testing of software and firmware to identify defects and ensure adherence to quality standards.

Design, configure, and maintain automated testing frameworks and tools to streamline the testing process and increase test coverage.

Collaborate with software developers, systems engineers and regulatory affairs to identify quality risks, establish acceptance criteria, and mitigate potential issues.

Perform root cause analysis of software defects and work closely with development teams to resolve issues in a timely manner.

Participate in design reviews, risk assessments, and validation activities to ensure compliance with regulatory requirements (e.g., FDA, ISO 13485).

Document test results, track defects, and generate test reports to communicate findings and facilitate decision-making processes.

Drive continuous process improvement and implement QMS updates, participating in internal and external audits as required.

Mentor and provide guidance to junior QA team members, promoting best practices in software testing and quality assurance.

Perform all activities in compliance with applicable regulations, Fractyl’s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.

Bring a “can do” spirit to work and deliver on other responsibilities as assigned.

Education or Certification Requirements

Bachelor’s or Master’s degree in Computer Science, Engineering, or related field.

Certification in software quality assurance (e.g., ISTQB) or related fields is a plus.

Professional Work Experience

Minimum of 7+ years of experience in software quality assurance, with at least 3 years in a senior or lead role.

Strong expertise in designing, implementing, and executing software test strategies and methodologies in a regulated environment (e.g., medical devices, healthcare, pharmaceuticals).

Experience with software validation, verification, and compliance with FDA regulations (e.g., 21 CFR Part 820, Part 11) and international standards (e.g., ISO 13485, IEC 62304).

Applicable experience in biotech, pharmaceutical and/or medical device industries preferred.

Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).

Qualifications and Skills

Experience utilizing requirements management tools (e.g., Helix, Doors, Jama)

Proficiency in automated testing tools and frameworks (e.g., Selenium, Appium, JUnit) and experience with test automation scripting (e.g., Python, Java).

Solid understanding of software development lifecycle (SDLC) processes, including Agile methodologies (e.g., Scrum, Kanban).

Excellent analytical, problem-solving, and troubleshooting skills, with a meticulous attention to detail.

Other Essentials and Key Success Factors

Successful track record of working in high-growth and dynamic organizations

Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit

Ability to lead fast-paced projects with a keen sense of urgency to get the job done well

Evidence of "hands-on" experience and expertise

Proven and successful track record as a team-player and collaborator in small working environments

Highly organized and detail oriented with a passion to deliver quality results

Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation

Highest levels of professionalism, confidence, personal values and ethical standards

Travel This position requires no regular travel.

The description and requirements outlined above are general; additional requirements may apply.

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