JT270 - SUPPLIER QUALITY ENGINEER I

qualityconsultinggroup; Villalba (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a motivated supplier quality specialist to join our team in the Puerto Rico and USA regions. You will work with cross-functional teams to ensure supplier quality across parts, materials and services in a world-class manufacturing environment.

The role emphasizes GMP/ISO 13485 and FDA regulatory awareness, strong analytical and communication skills, and the ability to negotiate with suppliers. First shift and English proficiency are required.

Qualifications

• Bachelor's degree in Engineering required.
• Minimum 1 year 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.
• Proficiency in English, written and verbal.

Responsibilities

• Ensure suppliers deliver quality parts, materials, and services.
• Qualify suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection.
• Monitor parts from acquisition through the manufacturing cycle and resolve supplier-related issues.
• Lead projects related to component acceptance activities and inspections processes.
• Develop and implement inspection plans.
• Review measurement qualification methods.
• Negotiate with suppliers to implement correct acceptance activities and inspections.
• Manage supplier qualification processes.

Skills

Problem-solving

Analytical skills

Communication skills

GMP knowledge

ISO 13485 knowledge

FDA regulations knowledge

Quality management systems

CQE/CSQP/Six Sigma (preferred)

English proficiency

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

Computer proficiency

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.
• 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.
• 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.