Javid Jk

Background

About Javid Jk

Implemented full quality management system for COVVI from scratch, Lead and achieved ISO 13485 and ISO 9001 certifications through successful BSI audits. This is achieved within short span of time.• Experience in supporting the full range of design control activities for medical device development, as well as product complaints, non- conformances, CAPA, post-market surveillance, patient safety and field escalations.• Supporting the review of design & development activities, remediated design control documents not limited to drawings, design, process, usability engineering, risk, bio compatibility, Labels and IFUs as per EU MDR.• Experienced in Process improvement, Quality System Management, Product/Process Validations.• Good knowledge in Statistical Principles and Applications, Project Management, Corrective and Preventive Action (CAPA), Failure Mode Effect Analysis (Process and Design), Control Plans, Root Cause Analysis, Production Part Approval Process (PPAP), Gage R&R, Design Verification & Validations, Process Validation & Verification protocols, DMAIC methodology, Sampling Plans.• Self-motivated individual with excellent communication and analytical skills, ability to work independently as well as in teams, strong researching skills and a quick learner.• BSI Certified Lead and Internal Auditor, have audited external suppliers and internal processes for compliance to ISO 9001 and ISO 13485• Manages a team of Quality Engineers.