**About Abbott Quality Engineer I**
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 Alajuela location. As the Quality Engineer I, you'll 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.
- 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 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.
- 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 mentorship from higher level engineering.
- Executing IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, typically with mentorship from higher level engineering.
- Conducting Advanced Statistical Data Analyses using Minitab typically with mentorship from higher level
- Maintenance/update to Master Validation Plans and Reports.
- Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.)
**Required Qualifications**
- Bachelor's degree in STEM.
- 0-3 years of experience.
- Knowledge of statistical, data analysis.
- Knowledge in process improvement tools such as: Root Cause Analysis, Fishbone,
- Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools.
- Knowledge with control of nonconforming material, corrective and preventive
- actions.
- Knowledge of FDA, GMP, and ISO 13485 regulations.
- Intermediate Commands of English.
- Availability to work fully on site.
**Preferred Qualifications**
- Prior medical device industry experience.
- Previous Quality Engineering experience.
- Experience with SAP ERP System.
- Knowledge on product and process qualification and validation.
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.