Omid Rahgozar
Cellophane: 647-***-**** Email: ****.********@*****.***
Professional Summary
Certified Quality Assurance Engineer and Lead Auditor with 15+ years of experience in the medical device, automotive, and electromechanical industries. Proven record of conducting 110+ supplier audits and ensuring compliance with U.S. FDA, Health Canada, ISO, IATF, CSA, and AS standards. Recognized for developing and implementing QMS frameworks, driving continuous improvement initiatives, and leading cross-functional teams across global operations. Adept in quality tools, Document Management, lean methodologies, and supplier development with a strong focus on operational excellence.
Core Competencies
Supplier Quality Auditing (ISO 9001, ISO 13485, IATF 16949, AS9100, FDA, Health Canada)
Quality Tools: FMEA, APQP, PPAP, MSA, SPC, 8D, FMEA, 5 Whys, Fishbone, Risk Analysis, Poka Yoke, 5S, Root Cause Analysis, SQA, NCR, Quality Control Plan, and Calibration
Continuous Improvement & Lean Manufacturing (Kaizen, CAPA, Nonconformance Management)
Joint Health and Safety Committee (JHSC) & OSSE Audit
Software: Pivot88, CAD, CATIA, Inventor, Visio, Syteline, Microsoft office, Power BI, Smartsheet
Mechanical & Electromechanical Systems: SMT, PCB, Plastic Injection, Medical Devices, Paint Line
Professional Experience
Specialist, Continuous Improvement – Garaventa Lift, Surrey, BC (2022 – Present)
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, corrective actions, and verifying effectiveness to avoid recurrence.
Served as Company Document Control Center Clerk, maintaining and organizing controlled documents in compliance with quality standards.
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 China, ensuring compliance with FDA, ISO 9001, and ISO 13485 standards.
Led 8 FDA internal audits and supported successful Health Canada inspections.
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
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 – S.G.S. Co. (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.
Quality Inspector – Celestica, Toronto, ON (2007 – 2008)
Inspected and tested 46+ PCB assemblies and electromechanical products.
Supported operators in ISO audit preparation and compliance with OHSAS/MSDS.
Quality Assurance Engineer, S.G.S. Co. (2002 – 2006)
Conducted 65+ supplier audits and authored 60 QC manuals.
Trained engineers on FMEA, Control Plans, and Fishbone Analysis.
Directed 90+ product and process verifications, calibration, and compliance checks.
Delivered supplier QA and quality systems training for manufacturing staff.
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
Lead Auditor (ISO 9001, ISO 19011, ISO 13485, ISO 14001, IATF 16949)
EN ISO/IEC 17025 Internal Assessment
Gemba Kaizen Workshop
Calibration
Six Sigma, SPC, DOE, MSA, Metrology & Calibration
SMETA – Ethical Audits for Responsible Supply Chains
Quality Tools: FMEA, APQP, PPAP, SPC, 8D, DOE, Poka Yoke, 5S
Strengthening business resilience with ISO 9001: the power of risk-based thinking
Technical Skills
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, Paint shop