HR Professional at Stryker
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Stryker - Quality Engineer/Senior Quality Engineer - Mechanical Engineering (3-7 yrs)
Quality Engineer or Senior Quality Engineer AQE
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.
- Minimum Qualifications :
Education : B. Tech / B.E / M. Tech / M.S. - Mechanical Engineering
Experience: Experience: 3-6 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
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