Supplier Quality Engineer II — Impact & Compliance

qualityconsultinggroup; Villalba (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC in Puerto Rico/USA is seeking a talented Supplier Quality professional to join our team. You will work with a cross-functional group to ensure supplier quality across medical devices, pharmaceutical, and biotech manufacturing.

The role emphasizes supplier qualification, CAPA, audits, and inspections, spanning from supplier selection to acceptance and transfer activities. English proficiency required; first shift.

Qualifications

• Bachelor's degree in Engineering.
• 3+ years of experience in Supplier Quality, Quality Engineering, or Manufacturing Quality.
• 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.
• 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 cross-functionally with teams and suppliers.
• ASQ CQE, CSQP, Lead Auditor, or Six Sigma certification preferred.
• Proficiency in English, both written and verbal.
• First shift

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

Skills

Supplier Quality

Quality Engineering

Regulatory Knowledge

Analytical Thinking

Cross-functional Collaboration

Education

Bachelor's degree in Engineering

Tools

CAPA

FMEA

Control Plans

Statistical Sampling

Job description

Quality Consulting Group, LLC in Puerto Rico/USA is seeking a talented Supplier Quality professional to join our team. You will work with a cross-functional group to ensure supplier quality across medical devices, pharmaceutical, and biotech manufacturing.

The role emphasizes supplier qualification, CAPA, audits, and inspections, spanning from supplier selection to acceptance and transfer activities. English proficiency required; first shift.