Quality Assurance Specialist
hace 5 días
About the Opportunity
This role is based in our Alajuela location in Costa Rica, within Abbott's Electrophysiology Division. We're pioneering medical technologies to treat heart disease and restore health.
In this position as a Quality Engineer I, you'll collaborate closely with Manufacturing and Engineering to ensure compliance with quality system requirements and Key Performance Indicators (KPIs).
You will be responsible for sustaining activities, process/product validation, and working with Research and Development and Regulatory Affairs personnel to maintain product and regulatory compliance.
Your Responsibilities
- Verify adherence to established Quality System and GMP/ISO standards
- Conduct investigations on NCMRs, Calibration OOT, and Complaint Investigations related to manufacturing processes
- Complete document change requests, ensuring accuracy, adequacy, and compliance to Quality System and product requirements
- Execute IQ, OQ, PQ, and/or PPQ qualifications and inspection and test method qualifications, typically with mentorship from higher-level engineering
Required Qualifications
- Bachelor's Degree in STEM (Science, Technology, Engineering, or Math)
- 0-3 years of experience
- Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint)
- Knowledge of statistical data analysis and process improvement tools (Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma, or Process Control & Monitoring)
- Knowledge of FDA, GMP, and ISO 13485 regulations
- Intermediate command of English
Estimated Salary Range: $65,000 - $90,000 per year, depending on experience and qualifications. The salary is competitive and reflective of industry standards in Costa Rica.
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