Job Information

Date Opened

07/16/2026

Job Type

Full time

Industry

Health Care

City

Bengaluru

State/Province

Karnataka

Country

India

Zip/Postal Code

560022

Supplier Quality Engineer

Responsibilities:

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 current 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.

📌 Supplier Quality Engineer (India)
🏢 Healthminds Consulting
📍 India