JT639 - SUPPLIER QUALITY ENGINEER II

Quality Consulting Group, LLC; Villalba (PR); On-site; USD 75,000 - 105,000; Full time

Job summary

Quality Consulting Group, LLC in Puerto Rico and the USA is seeking a talented Supplier Quality professional to join our manufacturing-oriented team. You’ll collaborate with cross-functional groups to assure supplier quality, support in audits, CAPA, and continuous improvement initiatives.

The role requires a engineering degree, 3+ years in supplier quality or manufacturing quality, familiarity with GMP, ISO 13485 and FDA regulations, and strong English communication.

Qualifications

• Bachelor's degree in Engineering.
• 3+ years of experience in Supplier Quality, Quality Engineering, or Manufacturing Quality.
• Experience in 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.
• ASQ CQE, CSQP, Lead Auditor, or Six Sigma certification preferred.
• Proficiency in English, both written and verbal.

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

Skills

Strong problem-solving, analytical, &沟

English proficiency

Certification preferred

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.
• 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