Quality Engineer Ll

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 Electrophysiology 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 II (MES), Electronic Device History Record (DHR), you will be responsible to work closely with Manufacturing and Engineering on implementation of Electronic (DHR) and 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 owns/lead process/product validation activities, in production lines. Also, work closely with Global MES Core Teams, 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. Own 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.
• Support/owns Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) with mentorship from higher level engineering.

Required Qualifications

• Bachelor´s Degree STEM (Science, Technology, Engineering (preferred), Math) (with equivalent experience in medical devices or pharmaceutical quality control).
• 1 - 2 years’ experience in Quality or Engineering positions.
• At least 1 year of experience in Quality or Engineering positions.
• Knowledge of statistical/data analysis and report writing experience.
• Knowledge 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.
• Knowledge with control of nonconforming material, corrective and preventive actions.
• Knowledge of FDA, GMP and ISO 13485 regulations.
• Knowledge on product and process qualification and validation
• _ Intermediate Command of English: _Capable of maintaining fluent oral and written communication face to face or by conference, and/or mail.
• SHIFT ADMIN

Preferred Qualifications

• Prior medical device industry experience.
• Previous Quality Engineering experience.
• Experience with SAP ERP System, MES.
• 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.