Pratik Kapadia

Experience

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  Versapet Inc.

  Sept 2016 - Apr 2018

  Quality Team Lead

  Inspected production lines as assigned for defects, removed defective items from production with the written quality procedure and reported defects to the appropriate manager. Ensured that all specified on-line quality checks were being performed properly and on a timely basis by Standard Operational Procedures and customer requirements. Ensured all employees followed GMP for product safety, and provided GMP and Health and Safety Training to new employees.Prepared test samples, and set up and operated automated laboratory instrumentation.Investigated and corrected analytical, instrumental, and procedural problems in conjunction with management.Assisted in investigating customer complaints, finding the root cause of the issue, and providing corrective actions. Analyzed and documented all test results, calculations, and observations and completed report summaries. Inspection of incoming packaging material and raw material as per specific sampling plan.Created shipping labels for all production lines as per the production schedule and supplied them to the line leader before the start of production.Issued NCR and provided information on it to the Quality Manager.Complied with company QA programs for monitoring supplier quality, including audits, controls, and other qualifiers. Show less

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  Nanowave Technologies

  May 2018 - Jun 2021

  Quality Inspector

  Performed inspection of precision parts and assemblies as per customer drawings and specifications (using tools such as Calipers, Height Gauges, Pin Gauge, and Micrometers).Inspected space products using CMM in accordance with quality systems & and procedures.Inspected and verified incoming parts/materials against paperwork, recorded any shortages, and rejected damaged goods.Generated First Article Inspection Reports.Collected data and generated non-conformance reports.Continue to identify and monitor Key Performance Indicators (KPI) and develop strategies to achieve KPIs. Reported any deviations of tolerances to the Manager.Affixed appropriate tags to approved or defective products.Performed miscellaneous quality assurance activities such as supporting final inspection, training inspector & and health and safety training,Assisted in problem-solving with quality, Engineering, and other production departments.Participated in Kaizen events and 5S initiatives Show less

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  Profound Medical Inc.

  Jul 2021 - now

  Quality Control Specilaist

  Assisted with monitoring and maintenance of the company’s Quality Management System, including all applicable procedures and instructions.Ensured that all employees were familiar with and followed document control procedures and good documentation practices. Performed training on these activities for new employees.Organized and stored quality records, enabling timely retrieval when necessary.Participated in design and development activities as required, assisted with the generation and maintenance of Design History Files, and ensured DHF compliance with applicable procedures and regulations.Assisted with the transfer of new designs to manufacturing, including quality control activities from production processes to shipment of the final product.Assisted with the execution and monitoring of quality system processes such as change control, complaint management, nonconforming product handling, returned goods processing, and CAPA.Provided support for the supplier management program. Evaluated and monitored suppliers' quality issues, and coordinated failure investigations and supplier corrective action requests promptly. Created reports on supplier performance.Assisted with management of the equipment maintenance program including equipment calibration, preventive maintenance, tracking of facility maintenance, and controlled environments for manufacturing.Performed inspection of finished devices and product device history records to ensure conformity with the quality management system and applicable regulatory requirements before a device was released. Tracked data metrics such as yield/scrap rates, failure modes, and target timelines for quality processes.Conducted Internal Quality Audits and supported the audit program as needed.Participated in and supported 3rd party audits and inspections (ISO, Health Canada, FDA, etc.). Show less