Senior Quality Engineer in Gurgaon, भारत

Senior Quality Engineer at Stryker responsible for managing change control and standards processes within a medical device quality management system. The role involves processing regulatory change requests, ensuring compliance with quality procedures, and driving process improvements in a hybrid work setting in Gurugram.

Responsibilities

• Process and manage Enterprise Change Requests and Notices in Windchill onePLM
• Assess, plan, implement, and document product changes per quality management requirements
• Facilitate cross-functional change implementation meetings and impact assessments
• Maintain and oversee standards management processes aligned with regulatory requirements
• Identify and execute process improvement opportunities; monitor compliance

Requirements

• Bachelor's degree in Engineering with 4-7 years of professional experience
• Hands-on experience with Windchill onePLM and TrackWise systems
• Proficiency in root cause analysis, quality control tools, and CAPA processes
• Demonstrated expertise in ISO 13485 quality management systems
• Strong knowledge of medical device change management and standards processes
• Understanding of FDA 21 CFR Part 820 and GDP requirements
• Analytical and problem-solving abilities with attention to detail