Verification And Validation Engineer

Job Description

Verification and Validation R&D Primary responsibilities: Represent the Design Quality function on device development project teams and cross functional co-ordination with multiple departments including R&D, Quality Control, Manufacturing and Regulatory Affairs. Ensure that device development projects and changes to existing devices are conducted in compliance with the FDA 21CFR Part 820 Quality System Regulation, ISO 13485 Regulations, and other applicable standards like ISO 14971. Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting devices can be adequately manufactured and verified. Lead or support design activities including design verification, validation, test procedure development, usability engineering, and risk management. Generate or apply statistical methods with appropriate risk-based justification. Hands-on experience in Design History File compilation / Technical file documentation. Support internal and external inspections/ regulatory audits. Promote continuous improvement in design control activities and use of quality tools with design team. In-depth knowledge and understanding of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, 21 CFR 4 Regulation of Combination Products, 14971 Risk Management Standard, MDD, MDR, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices Secondary responsibilities (Wherever applicable): Experience interacting with regulatory agencies and notified bodies Experience with process improvements, process qualification and validation. Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance.