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Senior Software Quality Engineer, Validation (Contract)

Company: Guardanthealth
Location: Redwood City
Posted on: September 16, 2020

Job Description:

Job Description (This is a Contract Position)

At Guardant Health, we leverage the most advanced technologies and work with leaders in many different fields to create the most impactful and meaningful technologies for cancer management.

To support Guardant Health s leadership in disruption of cancer treatments, the Software team is looking for an experienced and energetic software quality engineer to help drive software quality and continuous integration for an exceptional customer experience.

In this role, you will be responsible for performing software and computer system Verification and Validation (V&V), test execution, system risk assessments, audit remediation, and documentation authoring (SOPs, Work Instruction, FMEA, COTS/SOUP, Verification Validation Plan, Protocol, Report, traceability matrix, forms, etc.) in accordance to FDA and Medical Device regulations. In addition, you will find many opportunities to work on other software components of the Guardant software stack.

As a member of the team, you will:

Learn and work with leading technologies and dataset (human genomics)

Familiar and working knowledge of SDLC, FDA, and IEC 62304.

Work closely and lead internal and cross-functional teams to set up test environment, prepare test data, draft test cases/protocol and perform test execution, ensure timely and robust execution of testing as part of a regular release schedule and CLIA, IVD, or other regulatory submission.

Have deep understanding on performing verification and validation on complicated, integrated systems at the database level and via token, SQL scripts, API calls, and automated tool. Familiar with Oracle Database, MongoDB.

Provide accurate planning, clear strategies, and milestones for testing leading to successful implementation and timely project completion

Author a full suite of the software and computer system verification and validation documents (Verification Validation Plan, Protocol, Report, traceability matrix), and perform/document Risk Assessments (FMEA) and COTS/SOUP Risk Analysis.

Assist, Review, and editing Software Architecture and Design (SAD) and Software Design Specification (SDS) and other technical documents from technical team.

Write, review, update, and maintain GxP related process documentation (SOPs, Work instructions, Forms, etc.), such as Software Change Management, Software Development Life Cycle (SDLC), Configuration Management, Defect Management, etc. and provide training on these processes.

Assist with defining and implementing software quality improvement initiatives.

Train and mentor internal team on regulatory/compliance processes, concepts and best practices, including Software Development process, V&V, Change Management, and Configuration Management processes.

Provide guidance to internal IT team on V&V, Change and Configuration Management. Review and edit V&V documentation from internal teams.

Design, create, enhance, and maintain detailed validation test cases, user test scripts and conduct automated and manual testing, including verification, validation, and end-to-end testing

Report, track and escalate anomalies discovered during testing (All testing phases) and ensure closure on issues

Contribute to long-term planning and streamlining of the Computer System Verification and Validation procedures to increase efficiency in a compliant manner

Participate and provide solutions to address internal and external Audits finding with process enhancements and additional V&V activities, including V&V Plan, testing, and report.

Working knowledge of Corrective Action Preventive Action (CAPA) and Noncomformance (NCR), work with cross-functional teams to author and manage CAPA and NCR reports.

Perform other duties as assigned

Qualifications You have the ability to understand system architecture, design, implementation and succinctly develop test approach and test cases to deliver high-quality results.

You can work proactively, independently, efficiently and as part of a team on multiple tasks and projects, and quickly learn new technologies.

You have the ability to understand system architecture, design, implementation and succinctly develop test approach and test cases to deliver high-quality results.

You can work proactively, independently, efficiently and as part of a team on multiple tasks and projects, and quickly learn new technologies.

You enjoy an agile, fast paced and highly technical environment. You are comfortable with receiving and providing constructive feedback.

In addition, you bring:

5+ years of hands-on experience in Computer System Validation

Excellent communication and documentation skills.

Hands-on knowledge of procedures and best practices related to CLIA, FDA, GxP, CFR21 Part 11

Experience with authoring SOPs, forms, Validation Plan/Report, UAT, training materials, etc.

Hands-on knowledge of RDBMS (SQL or Oracle) and running software via the Linux command line

Hands-on experience with API testing using tools such as Postman, Advanced REST Client, SoapUI

Working knowledge of Corrective Action Preventive Action (CAPA) and Noncomformance (NCR), work with cross-functional teams to author and manage CAPA and NCR reports

Ability to articulate complex technical problems and business value to a wide business audience

Experience in debugging distributed systems and applications

Experience in analyzing and evaluating data transmissions between distributed systems

Strong experience in User Acceptance Testing (UAT) and testing of custom, complex business applications

Prior exposure to programming and scripting languages such as Java, Ruby, Python, Shell is a plus

Familiar with SDLC

Experience working in an Agile team

B.S or higher degree in Computer Science, Engineering, Bioinformatics, or a related study or equivalent project experience

Additional Information 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 .

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Keywords: Guardanthealth, Redwood City , Senior Software Quality Engineer, Validation (Contract), Other , Redwood City, California

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