Quality Specialist (Medical) - Intellectt INC

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.