Mithun Manikandan

→ Ensured regulatory compliance with SFDA guidelines for medical device
→ Prepare all relevant documents and submit the product registration for Medical Device marketing Authorization (MDMA)
→ Authorized Representative (AR) registration under Saudi Food and Drug Authority
→ Reviewed and approved labeling, packaging and materials for compliance with regulatory requirements
→ Liaised with SFDA and other regulatory authorities for product approvals & renewals
→ Conducted risk assessment to ensure compliance with changing regulatory and mitigate potential regulatory issues
→ Managed regulatory audits and inspection
→ Stayed update on evolving SFDA regulations and implementations necessary changes in company processes
→ Implementing and maintained Standard Operation Procedures (SOPs) for regulatory compliance and documentation
→ Implementing and maintained Quality Management System (QMS) in compliance with SFDA, GMB & ISO 13485 guidelines
→ Implementing and reviewing Standard Operating Procedure (SOPs) to ensure compliance with quality standards
→ Conduct Internal and external audits
→ Identify the root causes and implemented Corrective and Preventive Action (CAPA)
→ Performed process validation and qualification for manufacturing & packaging
→ Trained employees on quality assurance standard, ensuring adherence to company policies and regulatory requirements
→ Management Representative for regulatory audits and external audits.
→ Maintained documentation for regulatory inspections and audits

→ Completed precise measurements using special tools
→ Evaluated components and final products against quality standards and manufacturing specifications
→ Created and deployed best practices to improve efficiency and reduce defects
→ Reported repeated issues to QA manager and other departments, collaborating to identify issue roots and rectify problems
→ Maintained compliance with safety and clean area procedures
→ Provided quality assurance from every stage of product development process from manufacturing to packaging
→ Maintained control of quality records and material stored in the Quality Control quarantine area
→ Performed and documented visual and dimensional inspection and physical testing of incoming and in-process components and finished products
→ Trained junior staff department in implementations of various quality tools and procedures
→ Inspect visually medical parts for defects as outlined on the Work Order
→ Perform dimensions on medical parts using various calibrated calipers, OD micrometers, ID pins, gauges and computer programs to determine: depth, height, length, thickness, width and other dimensions blueprint specifies
→ Ensure the correct materials referred by the standard of ISO and ASTM and packaging is being used in accordance with the current Work Order
→ Improved productivity and eliminated redundancies by making sure all machine settings and all protocols are followed before each run during my shift
→ Responsible for maintaining calibration of measuring instruments and gauges
→ Made quality decisions (accepted or rejected) based on provided quality control outlines
→ Maintained and organized all records, documentation, reports, other files associated with QA engineers and inspection tasks
→ Good knowledge of ISO standard and ASTM standards of medical devices
→ Provided technical support to CAPA and resolved all quality issues
→ Ensured that all corrective and preventative actions were taken in the required timeline
→ Follow SOP at all times to ensure that both quality and other standard are all met accordingly

→ Evaluated quality standards and performed corrections to identify and resolve problems
→ Adhered to established policies, procedures and compliance for satisfactory auditing
→ Improved customer value using 5S and Lean Manufacturing Principles
→ Developed and provided a variety of reports according to customer standards and production performance
→ Followed quality standards and procedures to minimize errors and maximize customer satisfaction
→ Devoted special emphasis to punctuality and worked to maintain outstanding attendance record, consistency arriving at work ready to start immediately
→ Analyzing & recording the rejection analysis reports & reporting to higher officials
→ Preparing and analyzing information for the purpose of Monthly Review
→ In the WCM team as a member, in streamlining the process, continuous improvements in plant
During my 2.5 years tenure, I did a project on 'Over usage reduction in solder blocks' that was certified by Saint-Gobain as a WCM yellow belt (kaizen)