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Quality Engineer

  • Full Time, onsite
  • TekOne IT Services Pvt. Ltd.
  • Ponce Inlet, United States of America
Salary undisclosed

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Job Title: Quality Engineer

Location: Ponce, Puerto Rico

Job Description

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.