Quality Specialist (Medical)

Quality Engineer Location: Ponce, Puerto Rico Overview: Responsible for ensuring that manufacturing processes meet quality standards and compliance with regulatory guidelines.
Key Responsibilities: Develop, implement, and maintain quality processes and systems. Perform root cause analysis and corrective actions for quality-related issues. Conduct audits to ensure compliance with ISO and FDA standards. Collaborate with engineering and production teams to improve product quality. Oversee non-conformance management, CAPA, and complaint investigations. Support the validation of processes, equipment, and systems. Monitor and analyze key quality metrics to identify improvement areas. Qualifications: Bachelor's degree in Engineering, Quality, or related field. 5+ years of experience in quality engineering in a regulated environment. Experience with CAPA, NCR, and quality management systems (QMS). Knowledge of FDA and ISO regulations. Strong attention to detail with excellent communication skills.