Quest Resource Group is currently seeking a qualified Sr. Software Quality Assurance Specialist for our client based in White Plains, NY. This position will be responsible for assuring that our client's projects are complying with organizational procedures as well as regulatory regulations and standards through project planning facilitation, process mentoring, project design and peer reviews, and through the formal SQA audit process. The Sr. SQA specialist will provide the software project and functional management with insight into process implementation through audit results and advises the project team on how to implement software processes and standards to best meet the needs of the project.
Responsibilities will include:
. Coordinate development of the software project plan with software project personnel, including the development of the project audit schedule that will provide the project team with insight into compliance with internal processes and external regulations.
. Provide advice to the software development team regarding software process implementation on the project, as well as answer questions about software processes and process compliance issues throughout the project lifecycle.
. Plan for and gather the necessary data for completing individual software process or work product audits based on the defined audit schedule.
. Conduct software process and work product audits based on document reviews and interviews with appropriate members of the project team. Provide the results of the software process and work product audits to the software development team and SQA management in order to provide insight into project compliance with established plans, policies and procedures. Track software project non-compliances to closure.
. Support the software peer review and design review process through participation in scheduled reviews as requested.
. Monitor software development, maintenance, and SQA audit process documentation (policies, procedures, and worksheets). Document and submit revision suggestions to existing software processes and help develop new processes as needed based on changes to the overall software development process.
. Manage the implementation, administration, training, and maintenance of quality system related software applications from inception through retirement.
Experience: We are looking for an individual that meets the following criteria:
. 8 years or experience in a software development environment, with technical software engineering experience (design, coding, testing) essential.
. Experience in auditing would be highly preferred.
. Extensive knowledge of the external regulations and standards such as FDA 21 CFR Part 820 (QSRs), 21 CFR Part 11, ISO 13485 and the software processes in a medical device regulated environment would be exceptionally helpful.
. Excellent communication and writing skills, strong negotiation skills and skills associated with being an effective change agent.
Qualified candidates, please send resume and rate information to
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Thursday, October 02, 2008