Supplier Quality Engineer I — Launch Quality with GMP/ISO

Quality Consulting Group, LLC; Villalba (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a motivated professional to support the supplier quality function in a world-class manufacturing environment in Puerto Rico and the USA. You will ensure supplier performance, qualify suppliers, and drive quality through the procurement–production cycle.

Responsibilities include implementing inspection plans, negotiating with suppliers, and administering supplier qualification programs to ensure cost-effectiveness and compliance with GMP, ISO 13485, and

Qualifications

• Bachelor's degree in Engineering is required.
• 1 year of experience in Supplier Quality, Quality Engineering, or Manufacturing Quality is required.
• Knowledge of GMP, ISO 13485, FDA regulations, and quality management systems.

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 associated with component acceptance activities and inspections process.
• Implement and work with inspection plans.
• Negotiation with suppliers to implement correct acceptance activities and inspections process.

Skills

Quality engineering

Supplier quality

GMP knowledge

Cross-functional teamwork

Analytical thinking

English proficiency

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
• Negotiation with suppliers to implement correct acceptance activities and inspections process

Qualifications:

• Bachelor's degree in Engineering.
• 1 years of experience in Supplier Quality, Quality Engineering, or Manufacturing Quality.
• Knowledge of GMP, ISO 13485, FDA regulations, and quality management systems
• Strong problem-solving, analytical, and communication skills
• Ability to work effectively with cross-functional teams and external suppliers
• Computer proficiency
• ASQ CQE, CSQP, Lead Auditor, or Six Sigma certification preferred.
• Proficiency in English, both written and verbal