Position Summary

Key Responsibilities
- Develop, implement, and maintain the Supplier Quality Management program.
- Qualify, evaluate, and monitor suppliers through audits, performance metrics, and risk assessments.
- Lead supplier selection and approval activities in collaboration with Procurement and Engineering.
- Plan and conduct supplier audits in accordance with ISO 13485, applicable regulatory requirements, and internal procedures.
- Review supplier documentation including quality agreements, process validations, certificates, and change notifications.
- Investigate supplier-related quality issues and lead root cause analysis using tools such as 8D, 5 Whys, Fishbone, and FMEA.
- Drive corrective and preventive actions (CAPA) with suppliers and verify effectiveness.
- Monitor supplier quality KPIs including PPM, on-time delivery, NCR trends, audit findings, and responsiveness.
- Support incoming quality control activities and disposition of non-conforming materials.
- Collaborate with Manufacturing, R&D;, Regulatory Affairs,



and Operations to resolve supplier-related issues.
- Participate in product development projects by ensuring supplier quality requirements are incorporated during design transfer.
- Manage supplier change notifications and assess their impact on product quality and regulatory compliance.
- Support customer, notified body, and regulatory inspections related to supplier quality.
- Mentor junior quality engineers and contribute to continuous improvement initiatives across the quality organization.
- Ensure compliance with applicable regulatory standards including ISO 13485, FDA QSR/QMSR, and other relevant medical device regulations.

Required Qualifications
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, Electronics Engineering, or a related discipline.
- 7-10 years of experience in Supplier Quality, Quality Assurance, or Manufacturing Quality, preferably within the medical device or regulated m

📌 Senior Supplier Quality Engineer (Noida)
🏢 Shukra Pharmaceuticals
📍 Noida