Manager, Software Quality Engineering

Company: Guardant Health
Location: Redwood City
Posted on: May 4, 2022

Job Description:

Job Description Company Description Guardant Health is a pioneer in non-invasive cancer diagnostics and the first company to commercialize a comprehensive genomic liquid biopsy. Our proprietary digital sequencing technology is transforming cancer treatment by providing an accurate and precise picture of the individual genomic alterations that cause tumors to grow, change, and develop resistance to treatment. We have combined decades of scientific research, advances in laboratory technology, and our breakthrough innovation in liquid biopsy to create new tests that have already handled tens of thousands of samples. We believe our tests can accelerate new drug development and improve the lives of all patients fighting cancer. Our current products are just the beginning of what we hope to accomplish, and new uses of our platform are emerging. We succeed best by coordinating our creative talents and energies, working as a team to achieve results far beyond what any single individual could accomplish. We seek very talented people who want to be part of our fantastic team. Job Description The Manager, Software Quality plays an integral role on the Quality team and supports the company's compliance activities with the FDA Quality System Regulation and ISO 13485 as well as CLIA, CAP, NYSDOH and applicable state requirements. The Manager, Software Quality is involved with troubleshooting complex problems, implementing corrective actions, building effective teams, meeting project deliverables and Quality objectives. Given the wide variety of tasks involved in this position, the individual must demonstrate the ability to collaborate with other departments, analyze complex issues and identify opportunities for continual improvement. The Manager, Software Quality must exhibit leadership skills, sound judgment and analysis, decision making, the ability to remain professional under pressure, effective interpersonal skills, and the ability to effectively communicate across all levels of the company. Essential Duties and Responsibilities: Responsible for quality of process followed through software lifecycle. Provides guidance on regulations that apply to processes and deliverables (e.g., CAP, CLIA, NYS, IVDD, FDA, IEEE, ISO). Determines quality standards that apply and monitors outcome of regulated processes for appropriateness (often includes project or release documentation review and approval). Authorship of quality standards documentation and software process related SOPs as part of a QMS. Responsible for quality systems and validation of ancillary software systems and processes that support quality system Manage software quality processes and personnel. Provides direction and serves as a quality expert in software quality processes. Leads the development, implementation, and continual improvement of software quality processes and ensuring the integrity of the processes are maintained when changes are implemented. Ensures subordinates complete assignments using established guidelines, procedures and policies. Writes and/or implements changes to controlled software quality documents (e.g., SOPs, etc.) as needed Participate in audits by partners and supports site inspections by regulatory agencies Manages personnel, including organizing and prioritizing daily tasks, performing training, and developing the team Lead and /or participate on quality projects and improvements Report all concerns of quality and/or safety to the Supervisor or Safety Officer Create and maintain quality metrics required for management review and/or to report to senior management Responsible for identifying changes in the regulatory environment. Responsible for maintaining Software Quality compliance gap analyses. Responsible for driving process streamlining efforts. Provide training, guidance, and support the company for other Software Quality related activities Oversee and execute complex testing, perform in-depth statistical analysis, and interpret results independently. Design, create, enhance, and maintain data simulators and automated testing framework to ensure excellent testing coverage. Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable. Execute special projects as assigned Qualifications B.S. degree in a scientific discipline or equivalent. 8 years of quality experience in the Life Sciences Industry Experience in managing people in the Clinical, Investigational, and outcomes based setting. Experience with utilizing a Laboratory Information Management System is preferred. Strong professionalism, leadership, and communication skills. Ability to analyze and problem solve complex issues that impact document control, records control and training administration with minimal direction and make decisions or escalate concerns. Strong project management abilities. Ability to effectively communicate technical information to technical nontechnical audiences. Possess working knowledge of applicable local, state and federal laboratory regulations. Ability to proactively communicate consistently, clearly, and honestly. Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments. Ability to constructively challenge concerns and engage in transparent conversations. Ability to work effectively in a team environment and build strong working relationships. Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment. Proven attention to detail and accuracy. Effective organizational skills. High degree of initiative and self-motivation. Drive for results and continual improvement - Ensure procedures and processes are in place that lead to the delivery of quality results and continually assess their effectiveness to drive continual improvement. Experience with Microsoft Office suite and Internet for business use. Certification by ASQ or other industry- recognized professional organizations preferred Additional Information Covid Vaccination Policy: Starting January 7, 2022, Guardant Health will require all employees to be fully vaccinated to either (a) establish that they have been fully vaccinated against COVID-19; or (b) request and obtain an approved exemption from Guardant---s COVID-19 U.S. Vaccination Policy as a reasonable accommodation, as consistent with applicable laws. An employee is considered fully vaccinated against COVID-19 two weeks after receiving the second dose of a two-dose vaccine or one dose of a single-dose vaccination. Acceptable vaccines are approved or under emergency use authorization by the U.S. Food and Drug Administration (FDA) and/or the World Health Organization (WHO). In addition, fully-vaccinated employees will be required to maintain their fully-vaccinated status under this policy by obtaining, if applicable, any FDA-approved boosters. Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time. Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. All your information will be kept confidential according to EEO guidelines. To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants . Please visit our career page at: http://www.guardanthealth.com/jobs/ LI-KH1

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