Job Details


Senior Quality Assurance Specialist


Aug 08,2017
San Jose, California


Senior Quality Assurance Specialist (252947)
7 months contract
San jose, CA

In this role as Senior Quality Assurance Specialist, you will be an integral member of the quality assurance team whose primary role is to ensure that quality system requirements in relation to software are effectively established and maintained in accordance with 21 CFR 820, ISO 13485, 21 CFR Part 11, IEC 62304 and other regulations and guidances as applicable. The ideal candidate possesses a broad base of experience and a high level of technical depth applicable to medical device software design. 3-5 years in medical device industry What youll do Review off the shelf software, software development tools and software systems used in quality processes to determine appropriate validation requirements Advise Management on quality planning (both short term and long term) supporting and providing diagnosis of quality problems (both internal and external), corrective and preventive action (CAPA) programs and continuous improvement programs Identify compliance gaps and develop and execute strategies to close gaps in an efficient, technical, and compliant manner Create, review and approve software life-cycle documentation Create, review and maintain documentation necessary to document quality activities. Participate in the development, implementation and maintenance of the quality system. All other duties as assigned We hope you have Bachelors degree in Computer Science, Software Engineering or related area of study A minimum of 3-5 years relevant experience in Software Quality Assurance in a regulated environment (digital health care or medical device) Thorough understanding of 21 CFR 820, ISO 13485, IEC 62304, ISO 14971 requirements Demonstrated ability to articulate risk to product quality and quality system compliance Proficiency in risk analysis tools and techniques (e.g. Hazard Analysis, FMEA, Fault Tree, Pareto diagrams, cause-and-effect diagrams, 5 whys, etc.) Able to work independently with minimum supervision Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative attitude


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