Vista de conjunto

Abbott – Alajuela – JOB DESCRIPTION: MAIN PURPOSE OF 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 process/product validation activities. Works with Research and Development and Regulatory Affairs personnel (internal or external) to obtained support on sustaining activities to assure compliance with product and regulatory requirements. Support 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. Supports technical and statistical investigations concerning optimization and compliance to specification. Assist in measuring process capability, process controls, and …