Supplier Quality Engineer

Healthminds Consulting; Bengaluru; On-site; INR 1,200,000 - 1,600,000; Full time

Job summary

HealthMinds Consulting Private Limited is seeking a Supplier Quality Engineer in Bengaluru to drive supplier evaluation, qualification, and ongoing quality performance in the medical device/pharma sector.

You will coordinate with Procurement, R&D, and Operations to address supplier issues, manage SQAs and SCARs, and ensure audit readiness across regulatory standards.

Qualifications

• 5–7 years of experience in Supplier Quality Engineering in medical devices or pharma.
• Strong knowledge of ISO 13485, ISO 15378, FDA QSR, and EU MDR.
• Experience with Supplier Quality Agreements, SCARs, and supplier audits.
• Proficient in SAP and supplier data management.
• Excellent communication and cross-functional collaboration skills.
• Leading auditor certification preferred (ISO 13485 or ISO 9001).

Responsibilities

• Support supplier evaluations, selections, and qualification per regulatory standards.
• Monitor supplier performance with scorecards, audits, and KPIs.
• Draft, negotiate, and manage SQAs.
• Support issuance and closure of SCARs; review root cause analyses.
• Maintain supplier records in SAP and ensure audit readiness.
• Coordinate with procurement, R&D, and operations to drive improvements.
• Assist audits under FDA, ISO, and notified bodies.

Skills

Supplier Quality Engineering

Regulatory compliance

Cross-functional collaboration

Negotiation

Audits

CAPA

RCA

PPAP

Education

Bachelor's in Engineering or Life Sciences

Tools

SAP

FMEA

8D

Job description

HealthMinds Consulting Private Limited | Full time

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

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

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

Supplier Quality Agreements:

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

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

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

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

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

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

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

ü Supportmaster data governance and collaborate with Procurement and IT teams.

Documentation &Compliance Support

ü Supportsupplier-related sections of internal and regulatory audits (FDA, ISO, NotifiedBodies).

ü Ensuredocumentation practices follow Good Documentation Practices (GDP) and internalSOPs.

Audits & Qualification

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

ü Supportrequalification of existing suppliers and onboarding of new ones.

Qualifications and Skills:

• Bachelor'sdegree in Engineering, Quality, Life Sciences, or a related technicaldiscipline.
• 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.