Supplier Quality Engineer

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 of new.

• 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.

• 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.