Stryker Quality Engineer or Senior Quality Engineer AQE in Gurugram, India

AQE to drive overall quality approach during new product / process development. Drive coordination with different departments (such a R&D, AME, ME, Regulatory, Post Market Quality) to ensure the resulting part/product/process are safe, compliant and effective. Good understanding of customer need and shall guide the team to achieve process/product compliance, safety, reliability & effectiveness.,Education : B. Tech / B.E / M. Tech / M.S. – Mechanical Engineering Experience: Experience: 4-8 years Technical Skill Set : Experience on Medical Device Development process Experience on New Product Development process and various phases of new product development. Experience on Risk Management, different Risk Analysis tools and techniques Experience on ISO 14971, IEC 62304, 60601-1 family of standards Understanding of Quality Management Systems. (ISO 13485, 21 CRF 820, ISO 9001) Understanding of design requirement specification, detailed design requirements, Engineering Drawings, Verification & Testing documents, Product Validation documents Awareness on techniques used for Product Evaluation Experience on reviewing Design Outputs, Device Master Record, and Design History File Experience with various Quality Management & Quality Control tools Understanding of the concepts of PPAP & Advance Product Quality Planning ​Experience on Basic Statistics

Work From Home: No

Travel Percentage: None

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com