In this role, you will have the opportunity to:
- Perform duties as an individual contributor and/or team member with 100% hands-on work
- Participate in creating and updating of test protocols, the submission, execution, and review of test protocols in accordance with SOPs
- Record, report, and verify software defects to accurately depict the software requirements
- Participate in test design reviews and work closely with Software Engineering team toward the reporting and resolution of design issues and/or software defects
- Participate in Validation to ensure the software meets user needs requirements of user workflows for a regulated environment
- Provide test data to drafts of validation report, update traceability matrices and quality metrics
- Create change orders in document control system
- Participate in daily management using DBS tools
The Essential Requirements Of The Job Include
- BE/BS degree or equivalent work experience in Computer Science, Biology, BioMedical or related field.
- 2+ years of software validation testing experience in a regulated environment.
- Understanding of FDA and ISO regulations, e.g., design controls and risk management
- Excellent interpersonal, writing and communication skills, and troubleshooting skills and passionate about testing, product quality, and customer satisfaction.
- Experience with: Windows environments, Web application testing, and working knowledge of SQL, including the ability to run queries, and interpret results.
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About Cepheid
Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company’s GeneXpert systems and Xpert tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid’s broad test portfolio spans respiratory infections, blood virology, women’s and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company’s solutions deliver actionable results where they are needed most – from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.