Software Quality Specialist

SUMMARY POSITION:
The Software Quality Specialist’s primary responsibilities are software validation and representing Software Quality in software development projects. Cepheid employs a Lean Software Development process, and this role participates in SCRUM team activities to ensure that the team follows established procedures, reviews documentation for content and compliance, participates in risk management activities, and report, evaluate and review software defects.
SCRUM team representation includes ensuring that the established procedures are followed, that requirements are well defined and testing strategy is completed, that deliverables are generated and have the proper content, and participating in risk management activities.
Software validation is the major activity for this role, and responsibilities include participating in the generation and execution of validation protocols and creating the validation report.
ESSENTIAL JOB RESPONSIBILITIES:
Review and approve project documentation for compliance towards Cepheid's Quality Management System and relevant regulatory requirements
Participate in Risk Management activities throughout the entire Product Life Cycle
Build working relationships with stakeholders in Software Engineering, Program Management and Product Owner to ensure efficient collaboration and reduce product time to market
Participate in all software validation activities in the project, including preparation and/or execution of relevant validation protocols, and generating the validation report
Work closely with Software Engineering, Product Owner, Global Product Support and others to ensure product requirements and design meet intended use and user needs
Work closely with Quality Systems and Regulatory Affairs to ensure that established procedures in Cepheid's Quality Management System are compliant with the Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD) as well as all other applicable global regulatory requirements
Participate in failure investigations of customer complaints to ensure compliance to regulatory requirements, and that complaint resolution conforms to the intended use and user needs



MINIMUM REQUIREMENTS:
Education or Experience (in years):
A Bachelor's degree is required; advanced degree preferred, within Computer Science or molecular biology, or similar
Professional designations are not required but training and certification in Medical Device Software, Software Validation, Lean Principles etc. is advantageous
Minimum 5 years of experience in Software Quality Assurance role working with Software Validation, and preferably at least 2 years in a regulated medical device / diagnostic industry
Experience from working with Medical Device Data Systems, Cloud Deployed Software or similar in a regulated environment
Experience from performing risk management activities in the medical device / diagnostic industry



Knowledge and skills:
Understanding of quality systems methodology and applications
Advantageous with knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, ISO 13485, IEC 62304, IEC 62366, ISO 14971 and other applicable standards and regulations
Possess excellent analytical and troubleshooting skills, must be self-motivated, willing to learn new concepts, technologies and products
Have strong interpersonal, writing and communication skills
Wants to work in a fast-paced environment with and manage continuous changes and improvements
Is dedicated to quality software and customer satisfaction
Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals



Cepheid is part of Danaher Corporation, a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide.
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!


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