Quality Engineer Iv

hace 2 semanas

Alajuela, Costa Rica Abbott Laboratories A tiempo completo

**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 IV**, you will be responsible to 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 owns/lead process/product validation activities. Work 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. Own Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal). Responsible for developing and maintaining quality engineering methodologies and providing quality engineering leadership and support for commercialized products, manufacturing, and/or system/services support.

Work with minimum supervision and assignments are broad in nature and employee uses discretion to design project task and to bring the project to completion.

**What You’ll Do**
- Verify company’s adherence to the established Quality System and GMP/ISO standards. Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements.
- Completion of risk management, risk analysis including FMEA and Leading Build At Risk (BAR) Authorizations & Closures.
- Work with R&D/Design Quality to revise design verification and design validation plans for products based on performance specifications and risk analysis. Also, provide support to lower-level engineering positions.
- Supports technical and statistical investigations concerning optimization and compliance to specification, conducting advanced statistical data analyses using Minitab and also provide support to lower-level engineering positions.
- 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.
- Executing and authoring IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications. Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.). Also, provide support to lower level engineering positions.
- Authoring Master Validation Plans and Reports. Works closely with Sr quality engineering position on completing and documenting Monthly Quality Data Review, providing data analysis and escalation recommendations.
- Supports activities during preparation and execution of audits (External / Internal), functioning as SME backup for specific Quality activities.
- ** Shift B**

**Required Qualifications**
- Bachelor´s Degree Engineering.
- 4-6 years of experience in Quality or Engineering positions.
- At least 4 years of experience in Quality or Manufacturing Engineering positions
- Experience in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools.
- Project management experience, participating or leading multi-departmental project teams.
- Knowledge of statistical/data analysis and report writing experience.
- Experience with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementor.
- Experience working on FDA, GMP, and ISO 13485 Regulated environments.
- Advance Commands of English (Required Fluent oral and writing communication including technical writing).

**Preferred Qualifications**
- Experience with SAP.
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