Senior Quality Assurance Specialist

hace 4 semanas


Ponce, Ponce, Puerto Rico Intellectt Inc A tiempo completo

Quality Engineer Role at Intellectt Inc

At Intellectt Inc, we are seeking a skilled Quality Engineer to join our team. As a Quality Engineer, you will be responsible for ensuring that our manufacturing processes meet quality standards and comply 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.



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