Manager, Software Quality

5 - 7 years experience  • 

Salary depends on experience
Posted on 04/18/18
Redwood City, CA
5 - 7 years experience
Salary depends on experience
Posted on 04/18/18

Company Description

ABOUT OUR COMPANY

We believe conquering cancer is a big data problem. That’s why we built the world’s leading comprehensive liquid biopsy. This non-invasive tool for accessing and sequencing tumor DNA is used by thousands of oncologists to help tens of thousands of advanced cancer patients. We believe the boom in cancer data acquisition we helped launch will drive important discoveries and new products. We’re working on some exciting ones, including in early detection, where the impact on patients can be profound. We’ve raised more than $500 million from investors including Sequoia Capital, Khosla Ventures, OrbiMed, and SoftBank.

Job Description

ABOUT THE ROLE

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, and applicable state requirements. The Manager, Software Quality works closely with the Bioinformatics, Software, and Information Technology departments to support quality activities and identify opportunities for continual improvement.

The Manager, Software Quality must be an expert in software development life cycles to support various types of software and assure compliance to all applicable regulations for Guardant Health. The Manager, Software Quality must exhibit leadership skills such as good judgment, sound analysis and decision making, the ability to remain professional and composed under pressure, effective interpersonal skills, and the ability to effectively communicate across all levels of the company.

RESPONSIBILITIES

  • Provides guidance to the Bioinformatics, Software, and Information Technology departments on SDLC, SDLC documents, and associated SOPs
  • Collaborates with Bioinformatics, Software, and Information Technology departments on each new or revised software release and ensures the appropriate test cases and documentation are produced to assure a high quality product
  • Assures appropriate documentation is created, reviewed and approved for all new and updatesoftware applications
  • Reviews all software related documents (e.g. SOPs, records, plans, and reports) and provides input
  • Participate in requirements and design review meetings to provide input into test strategies/plans
  • Escalate anomalies discovered during testing and ensure closure on issues
  • Collaborate with Bioinformatics, Software, and Information Technology to ensure timely and robust execution of testing as part of a regular releaseschedule
  • Assist with defining and implementing software quality improvement initiatives
  • Represents Quality on all Bioinformatics, Software, and Information Technology project teams to ensure continual compliance
  • Capture, trend, and analyze quality data to report to management and drive continual improvement
  • Perform other duties as assigned

Qualifications

ABOUT YOU

  • Have an in-depth understand of SDLC’s and the appropriate documentation to support multiple types of audits
  • Understand both agile and waterfall models in a regulated environment
  • B.S or higher degree in Computer Science, Engineering, Bioinformatics, or a related study or equivalent project experience
  • 5+ years working in a regulated environment (CLIA, CAP, HIPAA, ISO 13485, FDA QSR, 21 CFR part 11)
  • Experience in compliance with quality standards in a regulated Molecular laboratory
  • Experience in interacting with auditors such as ISO and/or FDA
  • Understand system architecture, design, and implementation
  • Work proactively, independently and as part of a team on multiple tasks and projects, and quickly learn new technologies
  • Good knowledge of programming and scriptinglanguages
  • Prior experience in automation tools
  • Familiar with revision control software
  • Excellent organizational, problem-solving, and people skills
  • Excellent written and verbal communication skills
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