Quality Assurance

16 hours ago

Gurugram Haryana, India Human Capital Full time

Position - Quality Assurance Engineer (Medical Devices) Industry Preferences - Medical Devices Location - Delhi NCR **Job Description -** Risk Management, Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review, Review and approval of CER. - Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product. - Responsible to ensure provisions of Design Control processes are followed and associated reviews are conducted. - Participate in design reviews during various phases of NPD. - Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness. - Expert-level knowledge of current industry standards for New Product Development and risk management practices. - Solutions-based approach to quality engineering, wants to provide “added value" (“quality police” attitudes won’t survive in our culture). - Exposure to any Programming language & on Software Testing concepts. - Design And User Validation exposure. - Good interpersonal and communication skills. **Required Skills -** Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820) - AQE should drive coordination with different departments (such a R&D, Test, Regulatory, Clinical) to ensure the resulting part/product/process is safe, compliant and effective. - Experience on NPD process and various phases of new product development. - Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards. - Design and User Validation. - Participant and/or champion for Corrective Action and Preventative Action (CAPA) process. - Knowledge of IEC 62304 standard for Medical device software. - Establish world class risk methodologies for complex systems based upon existing corporate/divisional approaches. - Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews and the other practices mentioned above. **Job Types**: Full-time, Permanent **Salary**: ₹1,300,000.00 - ₹1,800,000.00 per year **Benefits**: - Health insurance - Provident Fund Schedule: - Day shift - Fixed shift - Monday to Friday Supplemental pay types: - Yearly bonus Work Location: In person

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