US: Software Quality Assurance Engineer
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please visit http://sqa.fyicenter.com
Software Quality Assurance 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 and update quality system SOPs, work instructions and other documents as needed.
•Review, analyze and report quality system data to identify trends and identify the need for corrective and preventive actions.
•Support Notified Body audits, customer/partner audits and FDA inspections.
•Support Corrective and Preventive Action (CAPA) to insure that all CAPAs involving software are correctly identified and entered into the CAPA system, assigned to the appropriate personnel, and completed according to CAPA procedures within the specified time periods. Ensure that CAPA investigations are appropriate and that effective actions are being implemented.
•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.
•Support QMS training activities and monitor process to ensure continued effectiveness. Work with managers to assign appropriate training requirements.
•Lead or support projects associated with new or revised compliance requirements.
•Other duties as assigned.
Required Education and Work Experience
•BA or BS degree (preferably in computer science).
•5 years SDLC experience as a member of a software development team.
•Understanding of medical device industry and Quality Management Systems.
•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