VIVEK RAPARKA
North York,ON
Summary
Meticulous Quality Control Technician successful at evaluating CLASS-II Medical Device components and finish products for adherence to tolerances. Highly effective at managing reporting requirements and solving problems in manufacturing environments. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brands.
Overview
4
4
years of professional experience
Work History
Quality Control Technician
Amico Patient Care
Richmond Hill, Canada
01.2021 - Current
- Inspected Incoming parts and Outgoing goods (Functionality/Assembly tests) by Interpreting Engineering Drawings (eDrawings Viewer, Excel)
- Investigated Customer Complaints/Returned Goods by Performing Root Cause Analysis (Forensic Engineering, Reverse Engineering OTS products), Wrote Failure Analysis Reports, Chaired product incident meetings, presented findings to Management, and Suggested Corrective & Preventive Actions (CAPA)
- Authored Standard Operating Procedures and Work Instructions following ISO 13485, MDSAP, Health Canada, FDA, GMP, Occupational Health and Safety Act (OSHA)
- Monitored daily performance of production team to identify and address issues affecting quality product output.
- Managed Calibration log and Preventive Maintenance of equipment by performing timely preventive maintenance and arranging third party calibration of equipment.
- Installed, and Validated (IQ, OQ, & PQ) Equipment after evaluating plant layout.
- Examined First-Off samples of raw materials before use in production of Suction Regulators as well Flowmeters.
- Evaluated any new, unknown risks or hazards for further analysis and decisions
- Troubleshoot Production issues and Related equipment issues.
- Investigated and Dispositioned Non-conforming Parts (NCRs), Inventory Adjustments [ERP (SAP)], and issued Supplier Corrective Action Request (SCARs) when necessary
- Implemented 1 design improvement and 2 material changes that were causing field failures
- Identified the root cause as effect of static electricity on metal ball and glass tube, to overcome the issue updated the Work Instruction and implemented the use of staticide in the manufacturing process
- Updated work instruction for Overbed Table manufacturing, to cease the use of WD-40 as it was affecting the functionality of the gas spring.
Quality Inspector
Q2 Management Inc
Newmarket, Canada
07.2019 - 12.2020
- Documented, filed and maintained proper inspection records and quality assurance documents.
- Reads and follows work instructions, work rules and directions
- Maintained organization and cleanliness of work area
- Completed evaluations by properly using various gauges, tools and equipment.
- Inspected, tested and measured materials, products and installations against specifications.
- Analyzed and interpreted blueprints, data and manuals to determine precise specifications.
- Notified supervisors about production problems and helped identify and correct concerns.
- Identified and resolved quality issues, escalating critical problems to supervisors.
Education
Post-graduation - Project Management
04.2019
Bachelor’s degree - Mechanical Engineering
07.2016
Skills
- Conflict Resolution
- Planning & organizing
- ERP – (SAP)
- Excellent Work ethics
- Report writing skills
- Gauge and Sensor Calibration
- Audit Assistance
- Corrective Actions
- Quality Assurance and Control
- Specifications knowledge
- JAVA Programming Language
- Automation scripting
- Automated and manual testing
References
REFERENCE AVAILABLE UPON REQUEST.
Timeline
Quality Control Technician - Amico Patient Care
01.2021 - Current
Quality Inspector - Q2 Management Inc
07.2019 - 12.2020
Lambton College - Post-graduation, Project Management
Gujarat Technological University - Bachelor’s degree, Mechanical Engineering
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