US-CA-Sunnyvale: Quality Assurance Engineer
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please visit http://sqa.fyicenter.com
Quality Assurance Engineer
* Organizational Management System Experience: Quality culture building, Project management, Team management, Interfunctional coordination, Employee training, Statistical analysis, Management reporting. * Quality System Experience: Technical writing, Procedure writing, Quality system structuring, Document control, naming, and version control , Corrective/preventive action, Internal quality auditing, Verification and validation, Change control and planning. * Regulatory Experience: Medical device regulation, Application of external standards, Auditing to an external standard, External regulatory audits, Laws and regulations, Risk management. * Basic Administration Experience: Basic office software applications, Online research, Critical reading, Filing and labeling, Typing / data entry, Proofreading, grammar, and spelling, Report and record generation, Multi project queueing and multitasking.
EDUCATION and/or EXPERIENCE Bachelor's degree in a related field (Business Management, Quality Assurance, Law and Regulation, Technical Sciences, Engineering) and a minimum of three years related quality system /organizational or operational management /regulatory compliance /quality auditing experience. Medical device and software design control experience strongly preferred. Certified Quality Auditor preferred.
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Team SQAFYI - Software QA Resource FYI