Quality Engineer IV

Job description

JOB DESCRIPTION:Quality Engineer III (Shift B) 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. The Opportunity This position works out of our Costa Rica – Alajuela location in the EP Division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer III, you will work 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). What You’ll Do Verify company’s adherence to the established Quality System and GMP/ISO standards. Completion of risk management and risk analysis including FMEA. Work with R&D/Design Quality to revise design verification and design validation plans for products based on performance specifications and risk analysis. Conducts 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 Advanced Statistical Data Analyses using Minitab with minimum mentorship from higher level engineering. Authoring Master Validation Plans and Reports Support/owns Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) with minimum mentorship from higher level engineering. Supports activities during preparation and execution of audits (External / Internal) Perform supervisor activities to Quality Technicians, if required. Required Qualifications Bachelor’s Degree in STEM careers. Engineering preferred. 2-4 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 written experience. 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. Advanced command of English language (required). Shift B (Monday to Friday 3:30 pm to 10:00 pm & Saturday 8:00 am to 3:30 pm) Works 100% on site Preferred Qualifications Prior medical device industry experience. ASQ CQE / Six Sigma or similar certification. Participation or leading multi-departmental project teams. Experience with SAP ERP System. Knowledge on product and process qualification and validation. 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. The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted. JOB FAMILY:Operations Quality DIVISION:EP Electrophysiology LOCATION:Costa Rica > Alajuela : Parque Industrial, Zona Franca Coyol S.A Edificio #44B, Call0, Avendia 2 ADDITIONAL LOCATIONS: WORK SHIFT:Crcww2Nt (Costa Rica) TRAVEL:Not specified MEDICAL SURVEILLANCE:Yes SIGNIFICANT WORK ACTIVITIES:Keyboard use (greater or equal to 50% of the workday), Work in a clean room environment