Location: Fremont CA
Duration: 7 Months+
Minimum 20 years of experience in applicable role.
Evaluating, investigating, tracking and completing complaints through effective and established complaint handling process.
Review designs, documents, records, for compliance to internal procedures and regulations.
Ensure proper justification of statistical analysis and hypothesis testing.
Participate in device risk management activities, support in establishing proper statistical controls in development and transfer to manufacturing processes, verity data integrity, electronic data storage and data sheet validations.
Review and coordinate with Validation for all test method and design validation, review activities related to Design Verification and Design Transfer of Medical Devices, ensure work product meets regulations.
Support scientific, complaint, and test failure investigations, Perform data trend analysis, where applicable. Participate in phase reviews, write Quality Procedures, as applicable.