Supplier Quality Engineer

Healthminds; Bengaluru; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

HealthMinds Consulting Private Limited seeks a Supplier Quality Engineer to drive supplier evaluation/qualification and ensure compliance with FDA QSR, ISO 13485, and EU MDR. You will lead SQAs, support audits, CAPA, and supplier data governance in SAP, collaborating across Procurement, R&D, and Operations.

The role requires 5–7 years in supplier quality, strong communication skills, and experience with GMP/GDP and validation protocols. Bengaluru-based, full‑time position.

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, or related field.
• 5–7 years of experience in Supplier Quality Engineering for medical devices or pharma.
• Knowledge of ISO 13485, ISO 15378, FDA QSR, EU MDR and supplier quality systems.

Responsibilities

• Support supplier evaluation, selection, and qualification in line with regulatory standards.
• Monitor supplier performance using scorecards, audits, and KPIs (PPM, OTD, CAPA).
• Draft and manage Supplier Quality Agreements (SQAs) and coordinate renewals.
• Support supplier audits, findings, and closure of corrective actions.
• Maintain supplier records and SAP data; assist GDP, GMP, and validation processes.

Skills

Supplier Quality Engineering

Cross-functional collaboration

Communication & negotiation

Quality tools: FMEA, 8D, CAPA, RCA, PP

Education

Bachelor’s degree in Engineering, Quality, Life Sciences, or related technical discipline

Tools

SAP

Job description

HealthMinds Consulting Private Limited | Full time

Supportsupplier evaluation, selection, and qualification processes in accordance withFDA 21 CFR Part 820, ISO 13485, and company-specific quality systemrequirements.

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

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

Supplier Quality Agreements:

Draft,negotiate, and manage Supplier Quality Agreements (SQAs), ensuring cleardefinition of responsibilities, regulatory requirements, and qualityexpectations.

Maintainup-to-date documentation and coordinate agreement renewals with suppliers andinternal stakeholders.

Support theissuance, investigation, and closure of SCARs in response to suppliernonconformances.

Reviewsupplier-provided root cause analysis and corrective action plans, ensuringeffectiveness and timely resolution.

MaintainSCAR logs, metrics, and documentation for internal and external audits.

Remediateand align supplier records in SAP by consolidating duplicate entries andassigning accurate SAP Supplier IDs.

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

Supportmaster data governance and collaborate with Procurement and IT teams.

Documentation & Compliance Support

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

Ensuredocumentation 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.

Qualifications and Skills:

• Bachelor’sdegree in Engineering, Quality, Life Sciences, or a related technical discipline.
• 5–7years of relevant experience in Supplier Quality Engineering, preferablyin the medical device or pharmaceutical industry.
• Strongknowledge of ISO 13485, ISO 15378, FDA QSR, EU MDR, and supplier qualitysystems.
• Demonstratedexperience in managing Supplier Quality Agreements, SCARs, and conductingsupplier audits.
• Proficientin SAP and supplier data management.
• Strongcommunication, negotiation, and cross-functional collaboration skills.
• Familiarwith quality tools: FMEA, 8D, CAPA, RCA, PPAP.
• CertifiedLead Auditor (ISO 13485 or ISO 9001) preferred.
• Workingknowledge of GMP, GDP, and validation protocols.