What are the responsibilities and job description for the Supplier Quality Engineer position at Shoolin Inc?
Job Title: Supplier Quality Engineer / Specialist
Location: MA
Experience: 5 Years
Employment Type: [Contract]
Job Summary
We are seeking an experienced Supplier Quality Engineer to ensure the quality and compliance of externally sourced materials and components. The ideal candidate will work closely with suppliers and internal cross-functional teams to drive quality improvements, manage supplier performance, and ensure adherence to regulatory and quality standards.
Key Responsibilities
- Manage supplier qualification, evaluation, and approval processes
- Conduct supplier audits (on-site/remote) to ensure compliance with quality standards
- Monitor supplier performance using KPIs and drive continuous improvement initiatives
- Lead root cause analysis (RCA) and corrective/preventive actions (CAPA) related to supplier issues
- Review and approve supplier documentation including specifications, test methods, and quality agreements
- Collaborate with Procurement, Manufacturing, R&D, and Quality teams
- Support incoming material quality issues and supplier-related deviations/NCRs
- Ensure compliance with FDA, ISO standards (ISO 13485/9001), and GMP/GxP regulations
- Participate in change control processes involving suppliers
- Support regulatory inspections and internal/external audits
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 5 years of experience in Supplier Quality / Quality Assurance
- Experience in regulated industries (Medical Devices / Pharma / Biotech)
- Strong knowledge of FDA regulations, ISO standards, and GMP/GxP
- Hands-on experience with supplier audits and qualification processes
- Experience with CAPA, deviation management, and change control
- Excellent problem-solving and analytical skills
Preferred Qualifications
- ASQ Certification (CQE, CQA) or Six Sigma (Green/Black Belt)
- Experience with quality systems (TrackWise, SAP, Veeva, EtQ, etc.)
- Strong knowledge of risk management (FMEA, HACCP)
- Experience working with global suppliers
Key Skills
- Supplier Quality Management
- Root Cause Analysis (RCA)
- CAPA & Deviation Management
- Supplier Audits & Qualification
- Regulatory Compliance (FDA, ISO, GMP)
- Risk Management (FMEA)