Rekha Sudheesh
Principal Qa Engineer at Abbott
Based in Ottawa, Canada
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Seniority
Director
Department
Information Technology
Location
Ottawa
Industry
Hospitals and Health Care
Company size
166K
Contact information
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r•••••••@abbott.com
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Background
About Rekha Sudheesh
Ensure compliance to FDA, ISO, Health Canada and other regulatory bodies • Serve as QA lead for multiple new products under development and ensure compliance to Design control requirements as per Quality system requirements(QSR) • Ensure compliance to all elements of the Design control -Design Verification,Design Validation, Design transfer,Risk management etc • Assuring that the instrumentation used by the various departments are validated, calibrated and under preventative maintenance program. • Authored many SOPS and Quality procedures • Faced successful FDA audit, WHO audit, ANVISA audit, EU audit, MCC audit, Korean FDA audit etc
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