Quality Control Engineer

hace 4 días


Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

**Job Summary**

We are seeking a highly skilled Quality Control Engineer - Medical Devices to join our team As a key member of our Quality Engineering team, you will be responsible for investigating manufacturing product quality and compliance issues, analyzing results, making recommendations, and developing reports. You will also optimize manufacturing processes using engineering methods such as Six Sigma and LEAN principles.

**Key Responsibilities:**

  • Investigate manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production phases prior to final product release based on engineering principles.
  • Analyze results and make recommendations for process improvements.
  • Develop routine training and documentation materials for production staff to ensure seamless knowledge transfer of project and manufacturing processes.
  • Update technical content of risk management files and documents (e.g., FMEA, QCP).

**Requirements:**

A Bachelor's degree in Sciences or Engineering and previous experience in Quality Engineering activities within the Medical Devices or Pharmaceutical industry are required. Excellent computer skills and bilingual proficiency in Spanish and English (verbal/written) are essential.

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