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., Co. Cs, 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

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.