Global Supplier Quality Engineer II (GMP/ISO)

Quality Consulting Group, LLC; Northern (KY); Hybrid; USD 80,000 - 120,000; Full time

Job summary

Quality Consulting Group, LLC seeks a Supplier Quality professional to drive supplier qualification and quality improvements for components and materials across medical devices and pharma manufacturing. You will ensure supplier performance, support CAPA activities, and collaborate with engineering and operations teams.

The role emphasizes GMP, ISO 13485, and FDA compliance, with engagement across both Puerto Rico and USA facilities. Strong analytical and communication skills required.

Qualifications

• Bachelor's degree in Engineering and 3+ years in Supplier Quality or related field.
• Experience in regulated industries (Medical Devices, Pharmaceutical, Biotechnology).
• Knowledge of GMP, ISO 13485, FDA regulations and quality management systems.
• Experience conducting supplier audits and supplier qualification activities.
• Proficiency in English (written and verbal).
• First shift.
• Strong problem-solving, analytical and communication skills.
• Ability to work with cross-functional teams and external suppliers.

Responsibilities

• Ensures suppliers deliver quality parts, materials, and services.
• Qualifies suppliers per 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 associated with 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

Skills

Supplier Quality

Quality Engineering

Manufacturing Quality

CAPA

Root Cause Analysis

FMEA

Control Plans

Statistical Sampling

Cross-functional collaboration

English proficiency

Education

Bachelor's degree in Engineering

Tools

GMP

ISO 13485

FDA regulations

ASQ CQE

CSQP

Lead Auditor

Six Sigma

Job description

Quality Consulting Group, LLC seeks a Supplier Quality professional to drive supplier qualification and quality improvements for components and materials across medical devices and pharma manufacturing. You will ensure supplier performance, support CAPA activities, and collaborate with engineering and operations teams.

The role emphasizes GMP, ISO 13485, and FDA compliance, with engagement across both Puerto Rico and USA facilities. Strong analytical and communication skills required.