Supplier Quality Engineer

Supplier Quality Engineer

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.
  
• 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.