Quality Engineer - Medical Devices

About the Role

We 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 improvements

Required 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 processes

Location : Gurgaon

Experience : 5–8 years

Qualification : Bachelor’s or higher degree in Engineering (Mechanical)