Strategic Supplier Quality Engineer II – Audits & Compliance

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 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