Experience

Bruush

• Canada
• Wellness and Fitness Services
• 1 - 100 Employee

• Quality Assurance Supervisor

  • Nov 2022 - Present

  • Maintaining quality management system documents for medical device. • Experience in managing medical device license in Canada and USA. • Supervision of staff. • Coordinated completion of tasks with other departments. • Worked independently and managed team. • Performed quality control and quality assurance on the medical device including visual inspection, measurements, and destructive analysis. • Provided solutions to difficult technical issues. • Working with documentations and approval from Health Canada. • Preparing documentations as per regulations from ISO 13485:2016, ISO 14971:2019, Health Canada, and FDA. • Prepared SOPs, and quality management documents. • Overlooking design and development of medical device. • Performing risk assessment. • Catered to customer complaints and performed root-cause analysis and CAPA on the complaints. • Managed complaint handling database (Gorgias). • Implementing root-cause analysis, non-conformance identification, investigation reporting, corrective action reporting, and preventive action reporting. • Providing training to staff. • Implementing principles of lean management and six sigma. • Performed internal audit in Bruush. • Performed mock-recall of the medical device. • Performed mock-reporting to regulatory bodies (Health Canada and FDA). • Organized and chaired quarterly management review meetings. • Presented continuous improvement information during the management meeting. • Implemented continuous improvement in the company. • Presented KPIs and evaluated key objectives of the company. • Performed post-market surveillance of the product from customers. • Analyzed post-market surveillance information. • Prepared design and development documentation. • Prepared process and service related documentation. • Thorough knowledge of ISO13485:2016, SOR 92/282, and 21CFR820. • Supervised external audit for ISO 13485:2016 certification. • Cleared stage 1 and stage 2 of ISO 13485:2016 certification. Show less



Healthcare Systems R&A Inc.

• Canada
• Research Services
• 1 - 100 Employee

• Clinical Research Associate

  • Nov 2022 - Apr 2023

  • Prepared systematic review and meta-analysis on treatment of Alzheimer’s disease as a part of grant approval from funding agency. • Performed systematic review using Zotero and Rayyan. • Performed meta-analysis using R statistics. • Performed thorough search of relevant funding agencies and approached these agencies for approval of funds. • Prepared critical study documents such as brochures, case report form and informed consent document. • Assisted in clinical trial registration process. • Promoted as Clinical Research Lead and supervised a team of 7 researchers. • Provided training to the researchers on the topic and prepared research timeline gantt chart. • Prepared inclusion and exclusion criteria for clinical study. Show less



Dr. T Bhasin Path Labs Pvt. Ltd.

• India

• Head Of Quality

  • Dec 2021 - Jul 2022

  • Managed biochemistry, immunology, microbiology, clinical pathology, and molecular biology laboratories. • Solved assays/process problems. • Managed quality control activity and calibration of equipment and reagents. • Provided support in replacement, implementation, and validation of new test methods/technology. • Provided support during external audits for approval from regulatory commitments. • Identified potential problems and suggested technical solutions. • Technical management of human resource, instruments, reagents, and tests performed in the laboratory. • Coordinated completion of tasks with other departments. • Worked independently and managed team. • Performed internal audits and managed the external audits. • Provided solution to difficult technical issues. • Worked with documentations and approval from Government of India for external audits. • Prepared documentations as per regulations from ISO 15189. • Prepared SOPs, and quality management documents. • Performed risk assessment. • Implementing root-cause analysis, non-conformance identification, investigation reporting, corrective action reporting, and preventive action reporting. • Provided training to staff. • Catered to customer complaints and performed root-cause analysis and CAPA on the complaints. • Followed principles of lean management and six sigma for improving laboratory working. • Supervised external audit for ISO 15189:2022 certification • Supervised external audits for establishing COVID laboratories on international airport. • Supervised external audits for establishing COVID laboratories on associated laboratories. • Established COVID laboratory at medical laboratory • Established COVID laboratory at international airport • Client received ISO 15189 certification for medical laboratory for 2 complete cycles. • Client received ISO 15189 certification for COVID laboratory Show less



Sri Guru Ram Das Institute of Medical Sciences & Research, VPO Vallah

• India

• Assistant Professor

  • Jul 2016 - Dec 2021

  • Taught graduate and postgraduate students. • Designed, executed, and interpreted experiments for developing, validating, and troubleshooting procedures. • Root-cause analysis, corrective and preventive action. • Managed biochemistry, immunology, and molecular biology laboratories. • Coordinated completion of tasks with other departments. • Solved assays/process problems. • Provided support during external audits for approval from regulatory commitments. • Managed quality control activity and calibration of equipment and reagents. • Technical management of human resource, instruments, reagents, and tests performed in the laboratory. • Catered to customer complaints and performed root-cause analysis and CAPA on the complaints. • Coordinated development of project strategy in consultation with colleagues. • Managed research and ethical committee and research projects. • Worked with documentations and approval from Government of India for external audits. • Prepared documentations as per regulations from ISO 15189. • Prepared SOPs, and quality management documents. • Performed risk assessment. • Implemented root-cause analysis, corrective action, and preventive action on issues. • Provided training to staff. • Worked independently and managed team. • Performed internal audits and managed the external audits. • Provided solution to difficult technical issues. • Followed principles of lean management and six sigma for improving laboratory working. • Established COVID laboratory • Client received ISO 15189 certification for medical laboratory for 3 complete cycles. • Client received ISO 15189 certification for COVID laboratory for 2 complete cycles. Show less