Chetan Kansara

Over 14 years of progressive experience as a mechanical, industrial and quality engineer. Result driven, able to work effectively in teams or independently and having outstanding track record in quality engineering, improvements, project management, project optimization and customer relations. Looking for Quality Assurance managing position. 

Quality Manager /Management Representative

Silcotech North America Inc., Bolton, Canada.                                                                                     Nov 2016 – till present

• Management Representative of Quality Management System. Implement and define the quality systems in accordance with regulatory requirements (ISO 13485, ISO9001, ISO14001 and FDA compliance).
• Ensure that the processes needed for the Quality Management System (QMS) are established, implemented, adhered to and updated as required.
• Manage a team of Quality Technicians and Quality Inspectors to manage tasks of inbound QC, outbound QC, and complaint handling. 
• Overview, manage and handle Quality audits – Regulatory & Certification audits, Customer audits, Supplier audits, Internal GMP audits. 
•  Provide support and oversight of change control, documentation control, NCRs, and Corrective Actions (CAPA). Review Customer complaints quarterly with departmental managers and create action plan wherever applicable.
• Create, collect and analyze Quality Key Performance Indicators (KPI) to identify actionable trends.
• Liaise with raw material vendors and third party for accomplishing regulatory documentation per Customer's requirement (RoHS, REACH, SVHC).
• Work in conjunction with Project Management and Customer team during inception of new project to thoroughly understand scope of quality control at each stage. This includes developing  fixture, jigs, measuring programs, Instron tensile and compression testing programs for ongoing measurements and functional testing. 
• Support engineering team during new designs and modifications in during such stages as risk analysis, design review, verification and validation.
• Ensure that records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records.
• Ensure that all new staff are aligned with requirements of the QMS related to their own roles and responsibilities. Provide updated training and documentation as necessary. 
• Ensure that the performance of the QMS is reviewed at planned intervals to ensure its continuing suitability, adequacy and effectiveness. This review means assessing opportunities for improvement and the need for changes to the QMS. 
• Overlooking HWIN now RPRA (resource productivity and recovery authority).

Quality Engineer 

Silcotech North America Inc., Bolton,  Canada.                                                                                    May 2011 – Nov 2016

• Prepare PPAP submissions to the Customer.
• Read and interpret blue prints, verifying product compliance, set up supplier rework, containment and review non-conforming parts.
• Organize & conduct group training on defect recognition and new or existing procedures/work instructions.
• Develop and enhance procedures for routine auditing (internal and external) and monitoring. 
• Manage the execution of audit plans related to auditing and monitoring and provide regular reports to management.
• Integration and communication of quality systems into the scope of existing business practices company-wide through normal day to day business interactions.
• Serves as a subject matter expert for Quality Systems, which includes one or more of the following: Document Management, Change Control Management, CAPA management and Complaints.
• Experience in creating and executing regulatory compliances, implementation of Occupational Health and Safety Act (OHSA) & regulations, administering programs for the control of liquid industrial and hazardous waste, and the Hazardous Waste Information System and Network (HWIS/ HWIN) including manifests.

Achievement: Developed entire quality management system for ISO 13485:2003, ISO 14001:2004, FDA 21 CFR Part 820 compliant and major contribution towards certification of these QMS. Significant reduction in scrap of diaphragm silicone spring force  product with application of SPC. 

Quality Engineer / Management Representative

Pro-Flange Limited, Cambridge, Canada                                                                                                                Mar 2010 – May 2011

• Responsible for troubleshooting quality issues, corrective actions and cost reduction
• Provide applications support and      respond to Customer inquiries 
• Organize, plan and conduct all required inspection and tests in accordance with contract documents 
• Generate material test report (MTR) and positive material identification report (PMI) for customer
• Develop and maintain systems for the maintenance and calibration of metrological equipments
• Perform internal audits to assure that allotted locations are in acquiescence with company documented procedures as they relate to the ISO 9001:2008 standard
• Participate in management meetings and continual improvement
• Responsible for ISO 9001:2008 Reassessment and surveillance audits
• Licence renewal and annual compliance report preparation and submission to Canadian nuclear safety commission

Achievement: Developed new procedures and training manual which helped in reduction of internal non conformances in production and provided quality engineering support to onsite team during manufacturing on multiple projects.

Quality Technician/Bending Coordinator

Fluid Motion Technologies, Mississauga, Canada.                                                                              Feb 2004 – Mar 2010

• Engineering: Assisting with design engineering to develop new products on 7 axis (Burger) tube bending machine and 2 axis Lang machine. Coordinating the introduction of new products, implementing and managing bending processes, to reduce inventories, improve production, product design and cost
• Project Implementation: Preparing drawings using AutoCAD for engineering and tool room machining for any new and existing projects. Monitoring all activities relating to the engineering changes to ensure all elements relating to the engineering changes are meeting the time line
• Quality assurance : Performing regular quality auditing, formulating corrective action plans and follow up on the implementations of corrective action
• PPAP : Updating and maintaining PPAP packages, control charts, visual aids, master samples

Achievement: Executed major changes in bending programs resulting in increased production rate by 20% and reducing set up time by 25%

Mechanical Engineer

HQ TECH Limited, Cambridge, Canada                                                                                                      Feb 2003 – Jan 2004

• Monitoring of process and new product introduction adhering to quality procedures and controlling of  incoming materials as well as finished products
• Implement supplier quality improvement initiatives, working with them to develop and improve incoming quality levels

• B.E. in  Mechanical Engineering (University of Pune, India)                                                          
• ASQ-Certified Six Sigma Green Belt (CSSGB)
• Certified Lead Auditor (RABQSA)                                                                                                                     
• ASQ-Certified Quality Engineer(CQE)                                                                                                          
• Technical Specialist (OACETT, The Ontario association of certified engineering technicians and technologists)
• Certification Engineering Technologist (OACETT C.E.T.) – in progress