Pratik Kapadia
Etobicoke,ON
Summary
Highly skilled Quality Systems Specialist with comprehensive experience in maintaining and improving quality management systems. Possess strong skills in identifying areas of improvement, conducting audits and implementing corrective actions to ensure compliance with regulations. Adept at monitoring adherence to quality standards in production processes, demonstrating efficiency, reliability, and a continuous commitment to product excellence and process optimization.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Quality System Specialist
Profound Medical Inc.
07.2021 - Current
- Assisted with monitoring and maintenance of the company’s Quality Management System, including all applicable procedures and instructions.
- Ensured that all employees are familiar with, and follow, document control procedures and good documentation practices.
- Conducted training sessions for newly hired staff.
- Managed and monitored quality training records for employees.
- Managed comprehensive training matrix and associated records.
- Organized and stored quality records, enabling timely retrieval when necessary
- Participated in design and development activities as required, assisted with generation and maintenance of Design History Files, and ensured DHF compliance to applicable procedures and regulations
- Assisted with transfer of new designs to manufacturing, including quality control activities from production processes to shipment of the final product
- Facilitated implementation and oversight of quality system processes including change control, complaint management, and nonconforming product handling.
- Provided support for the supplier management program
- Evaluated and monitored suppliers quality issues, and coordinate failure investigations and supplier corrective action requests in a timely manner
- Developed reports assessing supplier performance.
- Coordinated management of equipment maintenance program including calibration and preventive measures.
- 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 is released
- Monitored data metrics including yield, scrap rates, and failure modes for quality processes.
- Performed Internal Quality Audits and provided necessary support to audit program.
- Participated in and supported 3rd party audits and inspections (ISO, Health Canada, FDA, etc.)
Quality Team Leader
Nanowave Technologies Inc.
05.2018 - 06.2021
- Conducted inspections of precision parts and assemblies per customer drawings and specifications using tools like calipers, height gauge, pin gauge, and micrometers.
- Conducted inspections of space components utilizing CMM to meet quality standards.
- Inspected and verify incoming parts / materials against paperwork, record any shortages and reject damaged goods
- Created detailed First Article Inspection Reports.
- Compiled data to create detailed analyses of non-compliance issues.
- Consistently identified and monitored Key Performance Indicators(KPIs).
- Notified Manager regarding tolerance deviations.
- Applied tags to distinguish between approved and defective items.
- Performed miscellaneous quality assurance activities such as supporting final inspection, training inspector & health and safety training
- Collaborated with quality, engineering, and production departments to resolve complex challenges.
- Contributed to the success of various Kaizen events and 5S projects.
Quality Team Leader
VERSA PET
09.2016 - 04.2018
- Inspected production lines as assigned for defects, remove defective items from production with written quality procedure and report defects to appropriate manager
- Ensured that all specified on-line quality checks are being performed properly and on time basis in accordance with Standard Operational Procedures and customer requirements
- Ensured all employees follows GMP for product safety, provide GMP and Health and safety Training to new employees
- Prepared test samples, set up and operate automated laboratory instrumentation
- Investigated and corrected analytical, instrumental, and procedural problems in conjunction with management
- Assisted in investigating customer’s complaints, find root cause of issue, and provided 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 production schedule and supplied it to line leader before start of production
- Issued NCR and provided information of it to Quality Manager
- Complied with company QA programs for monitoring supplier quality, including audits, controls, and other qualifiers
Education
Quality Engineering Management -
Lambton College
08.2016
Bachelor of Electrical Engineering -
Gujarat Technological University
06.2013
Skills
- Quality Management Practices
- Six sigma methodologies
- CAPA management
- Quality auditing
- Product Quality Assessment
- Supplier quality management
Certification
- Henry Harvin Education
Timeline
Quality System Specialist
Profound Medical Inc.
07.2021 - Current
Quality Team Leader
Nanowave Technologies Inc.
05.2018 - 06.2021
Quality Team Leader
VERSA PET
09.2016 - 04.2018
Quality Engineering Management -
Lambton College
Bachelor of Electrical Engineering -
Gujarat Technological University
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