Supplier Quality Engineer

Supplier Quality Engineer

Supplier Quality Management:

ü  Support supplier evaluation, selection, and qualification processes in accordance with FDA 21 CFR Part 820, ISO 13485, and company-specific quality system requirements.

ü  Monitor and assess supplier performance using scorecards, audits, and key metrics (PPM, OTD, CAPA closure rates).

ü  Collaborate with cross-functional teams (Procurement, R&D, Operations) to address supplier issues and drive continuous improvement.

Supplier Quality Agreements:

ü  Draft, negotiate, and manage Supplier Quality Agreements (SQAs), ensuring clear definition of responsibilities, regulatory requirements, and quality expectations.

ü  Maintain up-to-date documentation and coordinate agreement renewals with suppliers and internal stakeholders.

SCAR (Supplier Corrective Action Request) Management:

ü  Support the issuance, investigation, and closure of SCARs in response to supplier nonconformances.

ü  Review supplier-provided root cause analysis and corrective action plans, ensuring effectiveness and timely resolution.

ü  Maintain SCAR logs, metrics, and documentation for internal and external audits.

Supplier Data & SAP Management:

ü  Remediate and align supplier records in SAP by consolidating duplicate entries and assigning accurate SAP Supplier IDs.

ü  Ensure all supplier information is current, consistent, and audit-ready in the ERP system.

ü  Support master data governance and collaborate with Procurement and IT teams.

Documentation & Compliance Support

ü  Review supplier-submitted documentation (e.g., CoCs, PPAP, FAI, Material Certifications).

ü  Support supplier-related sections of internal and regulatory audits (FDA, ISO, Notified Bodies).

ü  Ensure documentation practices follow Good Documentation Practices (GDP) and internal SOPs.

Audits & Qualification

ü  Support supplier audits, issue audit findings, and track closure of corrective actions.

ü  Support requalification of existing suppliers and onboarding of new ones.

Qualifications and Skills:

• Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline.
  
• 5–7 years of relevant experience in Supplier Quality Engineering, preferably in the medical device or pharmaceutical industry.
  
• Strong knowledge of ISO 13485, ISO 15378, FDA QSR, EU MDR, and supplier quality systems.
  
• Demonstrated experience in managing Supplier Quality Agreements, SCARs, and conducting supplier audits.
  
• Proficient in SAP and supplier data management.
  
• Strong communication, negotiation, and cross-functional collaboration skills.
  
• Familiar with quality tools: FMEA, 8D, CAPA, RCA, PPAP.
  
• Certified Lead Auditor (ISO 13485 or ISO 9001) preferred.
  
• Working knowledge of GMP, GDP, and validation protocols.