US-CA-Hayward: Senior Software Quality Assurance Engineer
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please visit http://sqa.fyicenter.com
Senior Software Quality Assurance Engineer
• Development of software QA documentation, such as: software quality plan, verification and validation protocols; development of operating procedures for software QA activities.
• Software design control activities, including: design reviews, code reviews, change control board reviews; reporting
• Review of software test engineering documents, such as: test plans, test cases, test procedures and verification and validation
• Oversight of software testing
• Software quality systems development, implementation and administration, including: documentation controls, configuration management, requirements management and tracing, defect tracking, design controls, audits, and maintenance and field upgrade activities.
• Software risk management activities, such as: risk management plans, risk analysis, and risk management reporting
• QA Support associated with the development, implementation and verification and validation activities that may be associated with ERP (Enterprise Resource Planning), CRM (Customer Relationship Management) and other similar business enterprise systems.
• B.S. degree in Computer Science, Engineering or related discipline.
• Minimum 5 years' software QA and/or testing experience within the medical device industry.
• Full understanding and experience in formal software QA testing processes for medical device and/or capital equipment development.
• Experience with software test engineering and automated testing, tools, and/or script development.
• Knowledge of QA systems and regulations in a medical device environment (including design controls, risk management/analysis, etc.).
• Proficiency at programming in C language and experience in programming embedded systems desirable. Familiarity/experience in Real Time Operating Systems desirable.
• Exceptional communication skills that demonstrate understanding of complex technical details, clarity of thought, and the ability to understand customers and their needs.
• Demonstrated ability to meet commitments and multi-task in a fast-paced work environment.
• Demonstrated attention to detail and organization in all aspects of work.
• Strong interpersonal skills and ability to work effectively in a team environment.
• Computer system knowledge, including hardware and operating systems.
• Working knowledge of software standards (e.g. IEC 62304, etc.).
• Proficiency in Microsoft Word, Excel and Access (desirable).
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Team SQAFYI - Software QA Resource FYI