North York, Ontario, Canada
Certified ISO 13485:2016/MDSAP internal auditor with hands-on experience of conducting internal audits in a medical facility. Experienced quality system specialist with a demonstrated history in process improvement,CAPA, NCRs, change control,Gap analysis, process validation, design and development and 5S system implementation.
• Certified ISO 13485:2016/MDSAP internal auditor with hands-on experience of conducting internal audits in a medical facility. • Practical experience of handling customer complaints and return goods authorization. • Proficient with using geometrical dimensioning and tolerance and interpreting engineering drawings. • Hands-on experience in using quality tools such as Pareto chart, Cause and effect diagram, Flowchart, Control charts, and histogram. • Implemented an effective flow of documents from Inbound Inspection to production and to Outbound Quality control which has led to better scheduling of production and Inbound quality Control priorities. • Created process flowchart for different departments of the company and analyzed the redundancy in the processes to decrease the lead time. • Conducted process failure mode effect analysis for different processes and products for design history files and documentation of the same. • Conducted internal audit for ISO 13485:2016/MDSAP for all required sections applicable in the company and initiated corrective action for major findings. • Documented the audit checklist for ISO 13485:2016 and reviewed the final findings of the internal audit for implementing corrective and preventive actions. • Participated in corrective and preventive action monthly meetings to review the status and progress of open/pending actions
• Checked dimensions of incoming parts in the company and reviewing its quality according to the instruction manual. • Co-ordinated in the implementation of ‘5S’ in the company premises to achieve efficiency in productivity and to ensure workplace safety. It also helped in reducing waste and elimination of scrap and organizing various elements in individual departments. • Communicated with suppliers for any nonconformance of received parts and or visiting the supplier facility to resolve any nonconformance in material