JT639 - SUPPLIER QUALITY ENGINEER II

Quality Consulting Group, LLC; Villalba (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, seeks a skilled Supplier Quality Engineer to join our team in Puerto Rico and the USA. You will work with a proactive team to ensure supplier quality from procurement through production in a regulated environment.

The ideal candidate has a Bachelor's degree in Engineering and 3+ years in supplier quality or manufacturing quality, with knowledge of GMP, ISO 13485, FDA regulations, and

Qualifications

• Bachelor's degree in Engineering is required.
• 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.
• Experience supporting New Product Development and product transfer activities.

Responsibilities

• Ensures suppliers deliver quality parts, materials, and services.
• Qualifies suppliers per company standards and may administer a Certified Supplier Program.
• Monitors parts from acquisition through manufacturing and resolves supplier issues.
• Leads projects related to component acceptance and inspections.
• Implements and works with inspection plans; negotiates with suppliers on acceptance activities.

Skills

Supplier Quality

Quality Engineering

CAPA

Root Cause Analysis

FMEA

Statistical Sampling

Cross-functional teamwork

English fluency

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