Quality Engineer - Querétaro Site

JOB DESCRIPTION Quality Engineer - Querétaro Site 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 Apply Now Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. Explore Location Close the popup No locations found Apply Now Save Job SHARE THIS OPPORTUNITY We give you the tools you need to discover your perfect job match, and the freedom and support to take your career to the next level. Share via email Share via Facebook Share via LinkedIn Share via twitter Share job link To your colleagues or friends Cancel Copy Link Get notified for similar jobs You'll receive updates once a week Enter Email address (Required) ACTIVATE Email should not be empty Please enter valid email Success! Successfully subscribed for similar jobs Failure! You have already subscribed for this job Failure! Failed to subscribed for similar jobs Success! Successfully subscribed for similar jobs Ok Failure! Ok Get tailored job recommendations based on your interests. Get Started profile icon 4 hours. Sign up Profile recommendations See more See less See next See even more No recommendations found Job seekers Also Viewed See more See less See next See even more No recommendations found Similar Jobs Quality Engineer Location Mexico - Queretaro Category Quality Quality Engineer About AbbottAbbott 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. Quality Engineer Location Mexico - Queretaro Category Quality Quality Engineer About AbbottAbbott 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. Sr. Software QE Location Mexico - Queretaro Category Quality About AbbottAbbott, global leading healthcare company, is investing in Mexico. We are building a manufacturing facility in Querétaro.In Abbott’s Electrophysiology (EP) business, we’re advancing the tr

• 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.

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

• 401k matching
• Health insurance
• Flight privileges