Job_Description":"

Supplier Quality Engineer

Responsibilities:

Supplier Quality Management:

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

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

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

Supplier Quality Agreements:

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

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

SCAR (Supplier Corrective Action Request) Management:

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

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





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

Supplier Data SAP Management:

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

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

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

Documentation Compliance Support

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

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

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

Audits Qualification

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

Support requalification of existing suppliers and onboarding of new ones.

📌 Supplier Quality Engineer (Bengaluru)
🏢 HealthMinds
📍 Bengaluru