Quality Engineering - Queretaro Site

Quality Engineer  

About Abbott 

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. 

Working at Abbott 

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: 

• Career development with an international company where you can grow the career you dream of. 

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. 

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. 

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 design validation plans for products based on performance specification and risk analysis. 

• Supports technical and statistical investigations concerning optimization and compliance to specification. 

• Owner of measuring process capability, process controls, and process validation / efforts. 

• Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities. 

• Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process. 

• Completing and Documenting Monthly Quality Data Review, providing data analysis and escalation recommendations with minimum mentorship from higher level engineering. 

• Leading Build At Risk (BAR) Authorizations & Closures. 

• Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements. 

• Creation and maintenance of Quality Plans and Reports, typically with minor mentorship from higher level engineering. 

• Executing and authoring IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, typically with minimum mentorship from higher level engineering. 

• Conducting Statistical Data Analyses using Minitab typically with mentorship from higher level engineering. 

• Maintenance/update Master Validation Plans and Reports. 

• Supports activities during preparation and execution of audits (External / Internal). 

• Perform supervisor activities to Quality Technicians, if required. 

Education:  

Bachelor’s career : STEM (Science, Technology, Engineering (preferred), Math) (with equivalent experience in medical devices or pharmaceutical quality control) 

Experience 

• At least 2 years of experience in Quality or Engineering positions. 

• Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint). 

• Knowledge of statistical/data analysis and report writing experience. 

• Experience working on FDA, GMP, and ISO 13485 Regulated environments. 

• Experience in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools. 

• Experience with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementor.  

• Knowledge on product and process qualification and validation. 

Other Qualifications and Education 

• ASQ CQE / Six Sigma or similar certification 

• Participation or leading multi-departmental project teams 

• Experience in supervision role 

Language proficiency : English Intermediate- advanced Required