Knowledge of Quality Management System modules such as Quality Incidents, Deviation, APQP, SPC, Investigation, CAPA, and Change Management in eQMS applications (Trackwise).
Working knowledge of Quality Tools (Process Mapping, Risk Analysis, Cause & Effect Diagrams, Pareto Analysis, etc.)
Prepare all relevant reports to communicate the quality health of projects and account.
Evaluate regulatory risks of processes, proceduresAssist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
Experience in ISO 13485, along with awareness of various harmonized standards as ISO 14971.Develop, implement and manage appropriate SOPs and systems to track and manage product-associated eventsSoftware Knowledge:
Trackwise 2.0, Super, MS office, Mercury, Wind-chill, AS400 and SAP.Having deep knowledge of End to End process of USFDA Complaint Handling Unit (CHU) Corrective Action and Preventive Action (CAPA),
Closure of Non- Conformity (NC), Root cause Analysis (5WHY, Fishbone Diagram, Tree concept etc.), Lean Six Sigma, Technical Investigations, Medical Device Reporting, Quality Inspection Procedures (QIP), Dynamic Control Plan (DCP) and leading all these activities by Change Management process (ECR, ECN etc.)Having Knowledge of 21CFR820, 510(K) application, Project Management, Regulatory Compliance and Life-cycle Management.
Salary: INR 3,00,000 - 4,50,000 P.A.
Industry:Medical Devices / Equipments
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
Contact Company:The Hi-Tech Robotic Systemz Limited
Address :P. No. A-18, Sector-34, GTPL, Gurugram, Haryana