Job Description:
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
Additional Info:
We would like to talk with you about our exciting projects we currently have ongoing. Please see guardanthealth.com/jobs for more information and to apply. [Click Here to Access the Original Job Post]
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 update software 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 release schedule
- 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 scripting languages
- Prior experience in automation tools
- Familiar with revision control software
- Excellent organizational, problem-solving, and people skills
- Excellent written and verbal communication skills
Requeriments :
Skills :
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Additional Info:
We would like to talk with you about our exciting projects we currently have ongoing. Please see guardanthealth.com/jobs for more information and to apply. [Click Here to Access the Original Job Post]