Software Quality Specialist-Temporary

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 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 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 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

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.


At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.


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