Software Quality Engineer in Sunnyvale, California at Cepheid

Date Posted: 11/6/2019

Job Snapshot

Job Description

Job ID: CEP004576

About Us

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at or follow us on Twitter (@CepheidNews).



      • Define test architecture and strategy for complex and integrated systems
      • Coordinate and Participate in requirements development, configuration and change control, and Go/No-Go decisions.
      • Write validation plans and reports
      • Create and Execute OQ and PQ protocols as needed
      • Guide project team to write quality documents related to software validation and reviews for effectiveness
      • Guide project team's offshore testers and ensures they develop appropriate test scripts based on the projects User and/or Functional requirements.
      • Define validation schedule, engage stakeholders to seek agreement on deliverables and responsibilities
      • Coordinate and conduct risk analysis
      • Review and approve change controls and other quality documents required to maintain the system in validated state
      • Participate in software supplier audits as needed
      • Maintains Non-product software inventory throughout the company
      • Participate in internal and external audits as a subject matter expert for computer systems

Job Requirements



    • BA/BS degree or equivalent work experience in Computer Science or related field or equivalent experience
    • A minimum 8 years of software testing experience
    • Must have completed several major computer systems projects (such as ERP, MES) with multiple release cycles and have working knowledge of software development lifecycle in FDA/ISO or other regulated field
    • Experience in cultivate and maintain contact with key customers, including IT and/or Business; working closely with vendors to complete required tasks
    • Experience in leading resolution efforts when issues are identified and escalate appropriately
    • Experience in proactively identify and assist in prioritizing opportunities to streamline testing and/or quality but still stay compliant
    • Must have experience with: Windows environments, Excel macros and/or complex spreadsheets, and SQL or other RDBMS systems
    • Be knowledgeable in QSR and 21 CFR Part 11 regulations
    • Possess excellent analytical and troubleshooting skills, must be self-motivated, willing to learn new concepts, technologies and products quickly
    • Have strong interpersonal, writing and communication skills, as well as dedication to quality software and customer satisfaction


    • Experience with other applications such as defect tracking, web-based applications, requirements management


    • Ability to work in different time zones and available to approve system go-live during scheduled customer downtimes (often occurs over the weekends).   

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.