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 onboarding of new ones.
Qualifications and Skills:
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Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline.
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5–7 years of relevant experience in Supplier Quality Engineering, preferably in the medical device or pharmaceutical industry.
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Strong knowledge of ISO 13485, ISO 15378, FDA QSR, EU MDR, and supplier quality systems.
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Demonstrated experience in managing Supplier Quality Agreements, SCARs, and conducting supplier audits.
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Proficient in SAP and supplier data management.
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Strong communication, negotiation, and cross-functional collaboration skills.
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Familiar with quality tools: FMEA, 8D, CAPA, RCA, PPAP.
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Certified Lead Auditor (ISO 13485 or ISO 9001) preferred.
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Working knowledge of GMP, GDP, and validation protocols.
