Product Quality Assurance Specialist
hace 5 días
About Abbott Laboratories
As a global healthcare leader, Abbott creates breakthrough science to improve people's health. With a focus on anticipating changes in medical science and technology, we're always looking towards the future.
At Abbott Laboratories, you can do meaningful work that matters, grow, and learn, care for yourself and your family, be your true self and live a full life. You will have access to:
Career development with an international company where you can advance your career.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies globally 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 location in the Electrophysiology Division. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through groundbreaking medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
As the Product Quality Assurance Specialist, you will be responsible for ensuring compliance with quality system requirements and achieving Key Performance Indicators (i.e., NCMR's, MA's, Yield, Cost Reduction projects, etc.). You will own/lead process/product validation activities, work closely with Research and Development and Regulatory Affairs personnel (internal or external) to obtain support on sustaining activities and during new product introduction to assure compliance with product and regulatory requirements. You will also own Major Quality System investigations (i.e., CAPAs, HHEs, StopShip, etc.) and audits (External / Internal).
Your Responsibilities
- Support technical and statistical investigations concerning optimization and compliance to specification.
- Provide support to lower-level engineering positions.
- Owner of measuring process capability, process controls, and process validation / efforts.
- Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process.
- Support Major Quality System investigations (i.e., CAPAs, HHEs, StopShip, etc.).
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 roles.
- 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.
- 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 multidepartmental project teams.
Estimated Salary: $90,000 - $110,000 per year
We Offer
- Competitive salary.
- Opportunities for career growth and development.
- A dynamic and inclusive work environment.
- A comprehensive benefits package.
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