Quality Engineer - Queretaro Site (Santiago de Querétaro)

Quality Engineer - Querétaro Site

Main Purpose of the Role

Works closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators (i.e. NCMR’s, MA’s, Yield, Cost Reduction projects, etc.) and support/owns process/product validation activities. Works closely with Research and Development and Regulatory Affairs personnel (internal or external) to obtained support on sustaining activities and during new product introduction to assure compliance with product and regulatory requirements. Support of Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal).

Main Responsibilities

• Verify company´s adherence to the established Quality System and GMP/ISO standards.
• Assist in completion of risk management and risk analysis including FMEA.
• Work with R&D/Design verification and de...