JT639 - SUPPLIER QUALITY ENGINEER II

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, a leader inthe 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.

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

Qualifications:

• 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.
• ASQ CQE, CSQP, Lead Auditor, or Six Sigma certification preferred.
• Proficiency in English, both written and verbal.
• First shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.