JT639 - SUPPLIER QUALITY ENGINEER II

Quality Consulting Group, LLC; Villalba (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC in Puerto Rico and the USA is seeking a talented supplier quality professional to join our team. You will assess and qualify suppliers, ensure compliance with GMP, ISO 13485, and FDA regulations, and support cost‑effective quality in a regulated manufacturing environment.

Responsibilities include supplier audits, CAPA and root cause analysis, and collaboration with cross‑functional teams on NPD and product transfers.

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.
• 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

Manufacturing quality

GMP knowledge

ISO 13485

FDA regulations

Quality management

Supplier audits

CAPA

FMEA

Six Sigma

ASQ CQE

CSQP

Lead Auditor

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
• 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.