Manager, Software Quality Engineering
Company: Guardant Health
Location: Redwood City
Posted on: May 4, 2022
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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
Keywords: Guardant Health, Redwood City , Manager, Software Quality Engineering, Executive , Redwood City, California
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