Supplier Quality Engineer II — First Shift | GMP & Audits

Quality Consulting Group, LLC; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a skilled Supplier Quality Engineer to join a fast‑growing team in the pharmaceutical, biotech, medical devices, and manufacturing sectors. You will drive supplier qualification, audits, and inspection processes across USA operations, with emphasis on GMP, ISO 13485, and FDA compliance.

The role requires 3+ years in supplier quality or quality engineering, a Bachelor’s in Engineering, and strong analytical and communication abilities.

Qualifications

• Bachelor's degree in Engineering is required.
• 3+ years of experience in Supplier Quality, Quality Engineering, or Manufacturing Quality.
• Experience in regulated industries (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.
• Proficiency in English, written and verbal.
• ASQ CQE, CSQP, Lead Auditor, or Six Sigma certification preferred.

Responsibilities

• Ensure suppliers deliver quality parts, materials, and services.
• Qualify suppliers per company standards and administer a Certified Supplier Program.
• Monitor parts from acquisition through manufacturing and address supplier-related issues.
• Lead projects related to component acceptance and inspections process.
• Implement inspection plans and review measurement qualification methods.
• Negotiate with suppliers to implement correct acceptance activities and inspections process.
• Perform supplier qualification activities.

Skills

Supplier quality

Quality engineering

Regulatory knowledge

CAPA / RCA / FMEA

Problem-solving

Analytical skills

Communication skills

Six Sigma / CSQP / CQE preferred

Education

Bachelor's degree in Engineering

Job description

Quality Consulting Group, LLC is seeking a skilled Supplier Quality Engineer to join a fast‑growing team in the pharmaceutical, biotech, medical devices, and manufacturing sectors. You will drive supplier qualification, audits, and inspection processes across USA operations, with emphasis on GMP, ISO 13485, and FDA compliance.

The role requires 3+ years in supplier quality or quality engineering, a Bachelor’s in Engineering, and strong analytical and communication abilities.