Supplier Quality Engineer

At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe. Job Title: Supplier Quality Engineer – Medical Devices Job Summary We are seeking a detail-oriented Supplier Quality Engineer (SQE) with experience in the medical device, healthcare products, or pharmaceutical industry to ensure the quality, compliance, and performance of suppliers throughout the supply chain. The ideal candidate will be responsible for supplier qualification, supplier audits, quality improvement initiatives, incoming quality management, and ensuring compliance with regulatory and quality requirements including ISO 13485, FDA 21 CFR Part 820, ISO 14971, and GMP. Key Responsibilities Supplier Quality Management • Lead supplier qualification, approval, and onboarding activities to ensure compliance with company and regulatory requirements. • Conduct supplier risk assessments and establish supplier quality agreements. • Monitor supplier performance through key quality metrics, including PPM, SCAR closure, on-time delivery, audit performance, and non-conformance trends. • Develop and maintain approved supplier lists (ASL). Supplier Audits & Compliance • Plan, perform, and lead supplier audits to assess compliance with ISO 13485, GMP, FDA QSR, and company quality requirements. • Support regulatory inspections and external audits involving supplier-related processes. • Track audit findings and ensure timely closure of corrective actions . Supplier Corrective Actions • Lead Supplier Corrective Action Requests (SCAR) investigations and resolution activities. • Conduct root cause analysis using quality tools such as 5 Whys, Fishbone Diagram, and Fault Tree Analysis. • Verify effectiveness of implemented corrective and preventive actions. Incoming Quality & Non-Conformance Management • Manage supplier-related non-conformances and material quality issues. • Review and disposition incoming inspection failures and supplier complaints. • Implement containment actions and coordinate supplier investigations. • Drive reduction of supplier defects and improve incoming quality performance. New Product Introduction (NPI) Support • Partner with R&D, Manufacturing, Purchasing, and Regulatory Affairs teams to support supplier selection for new products. • Review supplier process validation documentation and manufacturing capabilities. • Ensure supplier readiness for new product launches and engineering changes. Risk Management • Participate in supplier risk management activities in accordance with ISO 14971. • Support PFMEA, DFMEA, process risk assessments, and supplier risk mitigation plans. • Evaluate critical component suppliers and establish appropriate monitoring controls. Validation & Change Control • Review supplier validation documentation, including IQ/OQ/PQ and process validation reports. • Assess supplier change notifications and ensure compliance with change control requirements. • Support qualification and requalification of supplier manufacturing processes. Continuous Improvement • Drive supplier quality improvement initiatives using Lean Manufacturing and Six Sigma methodologies. • Analyze supplier quality trends and develop improvement plans. • Collaborate with suppliers to reduce defects, improve process capability, and enhance product quality. Documentation & Compliance • Maintain supplier quality records in accordance with QMS requirements. • Ensure supplier documentation complies with ISO 13485, FDA requirements, GMP, and internal procedures. • Support document control activities related to supplier quality and compliance. QMS – Additional responsibility • Support and maintain the Quality Management System (QMS) in compliance with ISO 13485 and regulatory requirements. • Lead and support CAPA (Corrective and Preventive Actions) investigations, root cause analysis, and effectiveness checks. • Perform Internal Audits, Supplier Audits , and support external regulatory audits (FDA, notified bodies). • Review and approve design documentation , including DHF (Design History File), DMR (Device Master Record), and DHR (Device History Record). • Participate in risk management activities (ISO 14971), including hazard analysis, FMEA, and risk control implementation. • Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs) for new product development and process validation . • Ensure compliance with Good Manufacturing Practices (GMP) and quality standards. • Handle non-conformance reports (NCR) and lead investigations for product or process deviations. • Support validation activities (IQ/OQ/PQ, software validation, process validation). • Drive supplier quality management , including qualification, monitoring, and performance evaluation. • Analyze quality data and implement continuous improvement initiatives (Lean, Six Sigma). Required Qualifications • Bachelor's Degree in Engineering, Biomedical Engineering, Manufacturing Engineering, Quality Engineering, Life Sciences, or related discipline. • 3-8 years of experience in Supplier Quality Engineering, Quality Engineering, or Supplier Development within Medical Devices, Healthcare Products, Electronics Manufacturing, or Pharmaceutical industries. • Strong knowledge of: • ISO 13485 • FDA 21 CFR Part 820 • ISO 14971 • GMP • Supplier Quality Management Systems • Experience conducting supplier audits and managing supplier corrective actions. • Strong root cause investigation and problem-solving skills. • Experience with…