Position Summary
Shukra Medtech is seeking an experienced and detail-oriented Senior Supplier Quality Engineer (SQE) to lead supplier quality assurance activities and ensure that purchased materials, components, and services consistently meet regulatory, customer, and company quality requirements. The successful candidate will work closely with suppliers, procurement, manufacturing, R&D, and regulatory teams to establish robust supplier quality systems, drive continuous improvement, and support product quality throughout the product lifecycle.
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 manufacturing industry.
- Strong knowledge of ISO 13485 and medical device quality management systems.
- Experience conducting supplier audits and managing supplier development programs.
- Proficiency in quality tools including SPC, FMEA, Control Plans, MSA, CAPA, 8D, and Root Cause Analysis.
- Experience with supplier qualification, process validation, and risk management.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong communication and stakeholder management abilities.
- Ability to manage multiple suppliers and cross-functional projects simultaneously.
- Willingness to travel for supplier audits as required.
Preferred Qualifications
- ASQ Certified Quality Engineer (CQE), Certified Supplier Quality Professional (CSQP), or Lead Auditor certification.
- Experience with FDA-regulated medical devices.
- Knowledge of GMP, GDP, and risk management principles.
- Familiarity with ERP and Quality Management Systems (QMS).
- Experience with statistical analysis software and data-driven quality improvement methodologies.
Key Competencies
- Supplier Quality Management
- Supplier Auditing
- Risk Assessment
- CAPA Management
- Root Cause Analysis
- Regulatory Compliance
- Continuous Improvement
- Cross-functional Collaboration
- Technical Documentation
- Negotiation and Supplier Development
- Project Management
- Data Analysis
Benefits:
- Health insurance
- Leave encashment
- Paid sick time
- Paid time off
- Provident Fund
Work Location: In person
