Quality Assurance Specialist
hace 1 mes
About Abbott Laboratories
We are a global healthcare leader, creating breakthrough science to improve people's health. Our vision is to be the best healthcare company in the world.
Why Choose Abbott?
We offer a dynamic work environment with opportunities for growth and development. You will have access to:
- A company recognized as a great place to work in dozens of countries around the world.
- A company that is recognized as one of the most admired companies in the world by Fortune.
- A company that values diversity and inclusion.
The Opportunity
This position works out of our Alajuela location. As a Quality Engineer I, you'll work closely with Manufacturing and Engineering on sustaining activities to ensure compliance with quality system requirements and achievement of Key Performance Indicators (KPIs). You will support process/product validation activities and work with Research and Development and Regulatory Affairs personnel to obtain support on sustaining activities to assure compliance with product and regulatory requirements.
Your Responsibilities
- Verify company adherence to established quality systems and GMP/ISO standards.
- Assist in completion of risk management and risk analysis including FMEA.
- Support 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.
- Conduct NCMR Investigations, Calibration Out of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process.
- Complete and Document Monthly Quality Data Review.
- Lead Build At Risk (BAR) Authorizations & Closures.
- Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements.
- Create and maintain Quality Plans and Reports, typically with mentorship from higher level engineering.
- Execute IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, typically with mentorship from higher level engineering.
- Conduct Advanced Statistical Data Analyses using Minitab, typically with mentorship from higher level engineering.
- Maintenance/update to Master Validation Plans and Reports.
- Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.).
- Collaborate with cross-functional teams to resolve quality issues and improve processes.
Requirements
- Bachelor's degree in STEM field (Science, Technology, Engineering, and Math).
- 0-3 years of experience in quality assurance or related field.
- Knowledge of statistical and data analysis techniques.
- Familiarity with process improvement tools such as Root Cause Analysis, Fishbone Diagram, Is/Is Not, Six Sigma, and Quality Tools.
- Understanding of FDA, GMP, and ISO 13485 regulations.
- Intermediate commands of English language.
- Ability to work fully on-site.
Preferred Qualifications
- Prior experience in medical device industry.
- Previous quality engineering experience.
- Experience with SAP ERP system.
- Knowledge on product and process qualification and validation.
We offer a competitive salary range of $60,000 - $80,000 per year, based on your qualifications and experience. This estimate may vary depending on factors such as location and performance.
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