Wipro
Location
Kolkatta | India
Job description
Wipro Kolkata is inviting applicant with Experience in Risk Management in Medical Devices Job Description- Be responsible for the product safety risk management deliverables and maintenances of Risk Management file during product development and during lifecycle management per ISO 14971 and product specific regulations and standards. Ensures product safety risk management deliverables are created, maintained, and stored in the Risk Management file during product development and during lifecycle management of product per ISO 14971 and product specific regulations and standards. Monitors and reports on the product safety risk management performance in the field and ensures deliverables are updated as needed. Evaluate process and product changes for their impact to the current Risk Management Files. Monitor post product data (e.g. Complaints, Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCRs), Customer Feedback information, etc.) for impact to the Risk Management Files
CRITICAL SKILLS REQUIRED Knowledge and understanding of regulations related to risk management and the development of safe hardware and software products including ISO14971, FDA Regulations 21CFR 820, EU MDR, IEC 60601-1, IEC 62304, and IEC 62366-1. Risk Analysis Methodology know-how (e.g., FMEA) Excellent interpersonal skills and the ability to influence Experience in creating risk management deliverables Clinical knowledge an advantage. Should be ready to relocate to Kolkata Experience- 3yrs to 6 yrs Only Immediate joiners are requested to applyJob tags
Salary
