JT639 - SUPPLIER QUALITY ENGINEER II

Quality Consulting GroupVillalba, PR

About The Position

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Requirements

  • Bachelor's degree in Engineering.
  • 3+ years of experience in Supplier Quality, Quality Engineering, or Manufacturing Quality.
  • Experience in regulated industries such as Medical Devices, Pharmaceutical, or Biotechnology.
  • Knowledge of GMP, ISO 13485, FDA regulations, and quality management systems.
  • Experience conducting supplier audits and supplier qualification activities.
  • Familiarity with CAPA, Root Cause Analysis, FMEA, Control Plans, and Statistical Sampling techniques.
  • Experience supporting New Product Development (NPD) and product transfer activities.
  • Strong problem-solving, analytical, and communication skills.
  • Ability to work effectively with cross-functional teams and external suppliers.
  • Proficiency in English, both written and verbal.

Nice To Haves

  • ASQ CQE, CSQP, Lead Auditor, or Six Sigma certification preferred.

Responsibilities

  • Ensures that suppliers deliver quality parts, materials, and services.
  • Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
  • Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
  • Responsible for projects associate to component acceptance activities and inspections process.
  • Implement and work with inspection plans
  • Review measurement qualification method.
  • Negotiation with suppliers to implement correct acceptance activities and inspections process.
  • Supplier qualification
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