Quality Assurance & Supplier Lead Auditor
Resume:
Omid Rahgozar
BC 647-***-**** ****.*@****.**
Professional Summary & Core Competencies
• Certified Quality Assurance Engineer and Lead Auditor with 16+ years of experience in medical device, automotive, polymer, and electromechanical industries.
• Conducted 150+ supplier audits, ensuring compliance with U.S. FDA, Health Canada, ISO 9001, IATF, CSA, CWB, AS9100, and ASME standards.
• Developed and implemented QMS frameworks, driving continuous improvement initiatives, CMM, Faro Aram and leading cross-functional teams across global operations.
• Skilled in quality tools, document management, lean methodologies, HSE, CMM, Faro Aram, Hardness tests and supplier development with a focus on operational excellence
• Auditing: ISO 9001, ISO 13485, IATF 16949, AS9100, FDA, Health Canada, ABS, Supplier Quality Assurance
• Quality Tools: FMEA, APQP, PPAP, MSA, SPC, 8D, 5 Whys, Fishbone, Risk Analysis, 5S, Root Cause Analysis, SQA, NCR, Quality Control Plan, Calibration, Poka Yoke
• Continuous Improvement & Lean Manufacturing: Kaizen, CAPA, SOPs, NCRs, KPIs, Supplier Quality Assurance
• Joint Health and Safety Committee (JHSC) & OSSE Audits
• Software: Epicor,Pivot88, CAD, CATIA, Inventor, Visio, Syteline, Microsoft Office, Power BI, Smartsheet
• Mechanical & Electromechanical Systems: SMT, PCB, Plastic Injection, Medical Devices, Assembly & Paint Line Professional Experience
Quality and EHS Supervisor – Dover TWG,, Surrey, BC-2026-Present
• Supervise a team of 4 Quality and HSE professionals, providing leadership, coaching, performance management, and daily operational support.
• Manage and oversee all incoming inspections, ensuring incoming materials and components comply with engineering specifications and quality standards.
• Direct and maintain the calibration program for over 100 measuring and test equipment, ensuring compliance with calibration schedules and applicable standards.
• Supervise in-process inspections throughout manufacturing to ensure product conformity, process capability, and compliance with quality requirements.
• Developed and implemented Quality Inspection Plans for the manufacturing and inspection of 12-ft complex gear assemblies, improving inspection consistency and product quality.
• Successfully planned, facilitated, and executed three major Kaizen events, improving operational efficiency, quality performance, and cross-functional collaboration.
• Manage the weekly Health & Safety Observation Program, including trend analysis, corrective actions, follow-up activities, and reporting to management.
• Successfully led the organization through an ABS (American Bureau of Shipping) audit, achieving successful compliance with no major findings.
Manage and coordinate all weekly, monthly, and annual inspections and preventive maintenance for facility systems, including: Environmental compliance programs, Electrical systems, Building compliance inspections, Elevators, Fire protection and life safety systems
• Chair the Joint Health and Safety Committee (JHSC), leading committee meetings, workplace inspections, hazard assessments, and regulatory compliance initiatives.
• Manage and coordinate the First Aid Attendant Program, ensuring adequate workplace coverage, training, and regulatory compliance.
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• Develop, coordinate, and deliver fire drill plans and emergency preparedness training, ensuring employee readiness and compliance with safety regulations.
• Conduct comprehensive orientation and onboarding training for all new employees and contractors, covering Quality Management System (QMS), Health & Safety, environmental requirements, emergency procedures, and company policies.
• Lead investigations of nonconformities, incidents, and safety concerns using Root Cause Analysis, 8D, 5 Whys, and CAPA methodologies.
• Collaborate with Production, Engineering, Maintenance, and Supply Chain teams to drive continuous improvement, reduce risk, and improve product quality and workplace safety.
• Ensure compliance with Quality Management System (QMS), Health, Safety, and Environmental (HSE) requirements, applicable regulations, and industry standards. Continues Improvement & Quality Assurance Specialist- Garaventa Lift, Surrey, BC -2022 - 2025
• Conducted 30+ internal audits as ISO 9001:2015 and FDA Medical Device QMS Internal Auditor.
• Implemented a company-wide paperless quality management system.
• Managed customer complaints and root cause investigations across multiple departments.
• Analyzed customer quality feedback and collaborated with cross-functional teams to evaluate company and quality KPIs, implementing effective resolutions
• Reviewed and addressed yearly customer survey results, working with teams to develop action plans for improvement.
• Led and closed 100+ CAPA/CAR cases, ensuring root cause analysis, risk mitigation, and long-term preventive actions to maintain compliance with ISO standards and FDA
• Investigated and resolved supplier and internal NCRs by coordinating cross-functional teams, implementing containment and corrective actions, and recovering over $40K in compensation.
• Served as the Company’s Document Control Clerk, maintaining and organizing controlled documents in compliance with quality standards, SOPs, work instructions, and company standard forms.
• Championed multiple Kaizen initiatives to streamline production processes, reduce defects, and improve efficiency, resulting in measurable cost savings and quality enhancements. Management Representative / Senior Quality Assurance Engineer – Savaria, Brampton, ON -2016 – 2022
• Developed and implemented Quality Management Systems (QMS) across Canada and abroad, ensuring compliance with FDA, and Health Canada.
• Led eight (8) FDA internal audits and supported successful Health Canada inspections.
• Created and developed over 50 Standard Operating Procedures (SOPs), Work Instructions, and Forms
• Designed and managed a paperless quality plan checklist system for tracking parts and products, integrating it with partners and major suppliers.
• Trained 80+ global staff on the Pivot88 system, validating its functionality and driving continuous improvements.
• Established preventive maintenance programs for 100+ machines, improving equipment reliability and reducing downtime.
• Enhanced packaging and shipping quality through barcode and paperless tracking systems.
• Administered and maintained the Document Control Management System (DCMS) to ensure compliance with ISO 9001 and FDA requirements.
• Oversaw Canadian Welding Bureau (CWB) compliance and certification processes for welding operations
• Developed and optimized Paint Line maintenance and chemical testing procedures, resolving recurring tank contamination issues
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Quality Manager and Inspector-Promark Tools and Manufacturing -Toronto, ON, 2016
• Conducted AS 9100and Iso 9001 certifications
• Develop over 25 quality plans and inspections checklists for aircraft, military, medical, welding, and fabricated parts.
• Performed about 100 incoming and in-process inspections, ensuring full compliance with customer and quality standards
• Prepared and submitted over 10 First Article inspections (FAIs) for aircraft components.
• Calibrated and maintained 15 measurement and inspection tools, ensuring accuracy, reliability, and traceability
Quality Assurance Consultant - BCI Academy, Toronto, ON -2015 – 2016
• Delivered auditor training programs in ISO 9001 and IATF 16949.
• Conducted internal audits and maintained QMS documentation.
• Supported product quality improvements and staff training initiatives. Supplier Chain Development & Polymer Quality Specialist - Sazeh Gostar Saipa, Karaj - 2009-2015
• Audited 90+ suppliers, negotiating 160+ annual contracts.
• Redesigned 15 polymer parts, reducing costs and improving durability.
• Managed JIT manufacturing for 9,000+ daily parts supplied to 5 auto assembly plants.
• Conducted price and cost analysis for 60+ auto parts to ensure competitive sourcing.
• Conducted 65+ supplier audits and authored 60 QC manuals.
• Trained engineers on FMEA, Control Plans, and Fishbone Analysis.
• IATF 16949 Automotive Manufacturing Audit Witness Experience Education
• B.Sc. Mechanical Engineering (Solid Design) – Central Azad University
• Diploma, Electromechanical Engineering Technician – George Brown College Certifications
• Quality Tools: FMEA, SPC, MSA, DOE, Poka Yoke, GD&T and Metrology
• ISO 16949, ISO 9001, ISO 19011
• EN ISO/IEC 17025 Internal Assessment
• Faro Arm
• Lead Auditing
• Calibration
• Risk Assessment
• Gemba Kaizen Workshop
• Cyber Security
• Product and Process Audit
• Gemba Kaizen
• Poka Yoke
• SQA
• Introduction of Plastic Injection Molding Design
• General Quality Control
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• SMETA – Ethical Audits for Responsible Supply Chains
• Strengthening business resilience with ISO 9001: the power of risk-based thinking Technical Skills
• 5S
• Faro Arm, CMM, Hardness Test
• FDA Codes & Medical Device Regulation (U.S. & Canada)
• Software: Pivot88, AutoCAD, CATIA, Inventor, Visio, Smartsheet, Microsoft office, Syteline
• Specialized Knowledge: Plastic Injection Molds, PCB, SMT, Calibration, Supplier Auditing, CSA, CWB, Mechanical, Electrical, Polymer Assembly lines, and Paint shop
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