Supplier Quality Engineer (Bengaluru)

Supplier Quality Engineer (Bengaluru)

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.

- Solid
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.