Overview
Supplier Quality Engineer Jobs in New York City Metropolitan Area at GxP Associates
Title: Supplier Quality Engineer
Company: GxP Associates
Location: New York City Metropolitan Area
Role Summary
We are seeking a motivated and detail-oriented Supplier Quality Engineer (0–3 years experience, Full-Time Role) to support supplier quality assurance activities and ensure that all externally sourced materials, components, and services meet defined quality standards and regulatory requirements. The role involves working closely with cross-functional teams to monitor supplier performance, ensure compliance, and contribute to continuous improvement initiatives across the supply chain.
Key Responsibilities
- Develop, implement, and maintain supplier quality management processes aligned with internal quality systems and regulatory standards.
- Conduct supplier evaluations, audits, and qualification activities to ensure compliance with GMP, ISO 9001, and applicable industry standards.
- Collaborate with Procurement, Manufacturing, and Engineering teams to resolve supplier-related quality issues.
- Lead root cause analysis (RCA) and implement corrective and preventive actions (CAPA) for supplier deviations and non-conformances.
- Monitor supplier performance metrics (KPIs) such as defect rates, on-time delivery, and quality compliance.
- Review and approve supplier documentation including quality agreements, inspection reports, and certifications.
- Support incoming material inspection strategies and risk-based sampling plans.
- Assist in continuous improvement initiatives with suppliers to enhance product quality and reliability.
- Ensure compliance with regulatory requirements including FDA, ISO, and other applicable global standards.
- Participate in change control processes impacting supplier materials or processes.
Required Skills & Experience
- 0–3 years of experience in Supplier Quality, Quality Assurance, or Manufacturing Quality (Freshers with strong internship exposure may also apply).
- Basic understanding of GMP, ISO 9001, and supplier quality systems.
- Exposure to CAPA, deviation handling, and root cause analysis tools (5 Why, Fishbone).
- Good understanding of manufacturing processes and quality fundamentals.
- Strong analytical, problem-solving, and communication skills.
- Ability to work effectively in cross-functional and fast-paced environments.
- Exposure to regulated industries such as pharmaceutical, medical devices, or manufacturing is an added advantage.
Preferred Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related field.
- Internship or project experience in quality, manufacturing, or supplier management.
- Familiarity with quality systems tools or ERP systems is a plus.
