Quality Engineer - Medical Devices

About the RoleWe are looking for a Quality Engineer to ensure compliance with medical device quality standards and drive supplier performance improvements. This role involves supplier audits, risk management, and quality system assessments to meet global regulatory requirements.Key Responsibilities- Plan and conduct supplier quality system assessments, including preparation, scheduling, and follow-up actions - Assess supplier capabilities through site visits, technical discussions, and quality audits - Prepare detailed assessment reports and communicate quality issues to suppliers, driving corrective actions - Collaborate with corporate and regional quality teams on policy and guideline development - Track and trend supplier performance, implement remedial actions, and maintain ERP vendor profiles - Support suppliers in statistical sampling plans, inspection methodology, and quality procedures - Ensure compliance with ISO 13485, 21 CFR Part 820, and other regulatory standards - Handle SCARs, CAPA, NCEP, and audit outcomes - Lead activities related to product recalls, risk management, and process validation - Perform data collection, statistical analysis, and implement Six Sigma methodologies for supplier improvementsRequired Skills & Qualifications- 5+ years of experience in medical device manufacturing and supplier quality - Lead auditor certification or experience with ISO 13485 audits - Strong understanding of medical device regulatory requirements for Class II & III devices - Hands-on experience in risk management, CAPA, and post-market surveillance - Skilled in Six Sigma tools, SPC, DOE, Measurement System Analysis, and reliability techniques - Proficient in vendor management systems, supplier onboarding assessments, and procurement processesLocation: GurgaonExperience: 5–8 yearsQualification: Bachelor’s or higher degree in Engineering (Mechanical)

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