Senior Quality Engineer
On-siteGrecia, Provincia de Alajuela, Republic of Costa Rica
Job Summary
Lead investigations of non-conformances and implement corrective and preventive actions to support timely issue resolution. Collaborate with Engineering, Production, and cross-functional teams to ensure products and processes meet quality requirements. Support internal and external audits by preparing documentation, participating in audit activities, and addressing audit observations. Monitor, analyze, and trend quality data to identify risks, recurring issues, and improvement opportunities. Ensure compliance with the Quality Management System and applicable regulatory requirements, including 21 CFR Part 820, ISO 13485, and MDSAP. Apply statistical analysis and risk management tools, including FMEA, to support decision-making and continuous improvement initiatives.
Required Qualifications
- Bachelor's degree in Engineering or a related technical field
- Minimum 3 years of experience in Quality Engineering
- Working knowledge of 21 CFR Part 820, ISO 13485, and the Medical Device Single Audit Program (MDSAP)
- Advanced English proficiency, written and verbal
Desired Qualifications
- Experience supporting internal and external quality audits
- Experience conducting investigations, risk assessments, and corrective and preventive action activities
- Experience working in a regulated manufacturing environment
- Experience using statistical analysis and quality risk management tools
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