US-MN-Eagan: Sr. Software QA Engineer
To see other opportunities,
please visit http://sqa.fyicenter.com
Sr. Software QA Engineer
•Perform, facilitate and participate in risk management, software risk analysis, post-market customer feedback, failure trending and failure analysis.
•Perform, assist, review and/or provide coordination and guidance in external validation, traceability and testability of product software.
•Identify software quality challenges and software quality improvement opportunities and provide information to facilitate and support long-term planning.
•Review, analyze and report quality system data to identify trends and identify the need for corrective and preventive actions.
•Approve corrective action plans and verify effective implementation of corrective actions for audit nonconformities.
•Assist the development team in developing compliant templates, practices and documentation.
•Develop and review software regulatory documentation for appropriateness, correctness and effectiveness.
•Provide quality system training for the organization.
•Lead or support projects associated with new or revised compliance requirements.
•5 years SDLC experience as a member of a software development team.
•Understanding of medical device industry and Quality Management Systems.
•BA or BS degree (preferably in computer science).
•Ability to understand and interpret regulations and support the development of processes to meet regulatory requirements.
•Hands-on experience with quality systems regulations and guidelines.
•Ability to develop clear, concise, and timely oral and written reports.
•Strong written and verbal communication skills and interpersonal skills to effectively translate ideas, concepts and information.
To apply for this position, please visit
Team SQAFYI - Software QA Resource FYI