Manufacturing Process Specialist

hace 2 semanas


Ponce, Ponce, Puerto Rico Intellectt Inc A tiempo completo

Job Title: Manufacturing Quality Engineer

Location: Ponce, Puerto Rico

Overview: At Intellectt Inc, we are seeking a skilled Manufacturing Quality Engineer to develop, optimize, and maintain manufacturing processes that ensure efficient production and high-quality products.

Key Responsibilities:

  • Design and implement manufacturing processes for new and existing products.
  • Lead process improvement initiatives to enhance productivity and reduce costs.
  • Troubleshoot and resolve production-related issues.
  • Conduct process validations (IQ/OQ/PQ) and ensure equipment readiness.
  • Develop and maintain manufacturing documentation.
  • 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.
  • Collaborate with quality and operations teams to support compliance activities.
  • Monitor key performance indicators (KPIs) and drive continuous improvements.

Qualifications:

  • Bachelor's degree in Engineering or related field.
  • 5+ years of experience in manufacturing engineering.
  • Experience with CAPA, NCR, and quality management systems (QMS).
  • Knowledge of FDA and ISO regulations.
  • Strong attention to detail with excellent communication skills.
  • Expertise in lean manufacturing and process optimization.
  • Experience with process validation and equipment commissioning.
  • Strong knowledge of manufacturing standards (ISO, FDA).


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