Job ID: CEP000546
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 www.cepheid.com or follow us on Twitter (@CepheidNews).
Participate in the verification and validation of Cepheid's software applications. Primarily responsible for the quality of Cepheid’s product software shipped to customers. Secondary responsibilities may include verification and validation activities for non-product software used in manufacture of medical devices or quality systems or verification and validation activities for system software used throughout the company.
- Perform duties as an individual contributor and/or team member with 100% hands-on work.
- Participate in requirements development, risk analysis, configuration and change control, and Go/No-Go decisions.
- Plan, schedule, write, and execute software test documentation.
- Record, report, and track defects to accurately depict the status of the software projects.
- Work closely with Software Engineering staff toward the reporting and resolution of design issues and/or software defects.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES (MINIMAL COMPETENCIES)
- BA/BS degree or equivalent work experience in Computer Science or related field or equivalent experience
- A minimum of 4 to 6years of software testing experience
- Must have completed several major projects with multiple release cycles and have working knowledge of software development lifecycle in FDA/ISO or other regulated field
- Must have experience with: Windows environments, Excel macros and/or complex spreadsheets, and SQL or other RDBMS systems
- Have experience in all aspects of software testing: developing test plans, traceability matrixes, test cases, test protocols, test data, etc.
- Be knowledgeable in QSR and 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 an office and lab environment