Shahzad Umar947-236-7658-Text (Prefer)Shahzad.Umar17@gmail.comOBJECTIVESearching for a challenging position to utilize my education, skills, and overall work experience in the Medical Device and Automotive industries. SUMMARYMedical Device Experience Highlights:• Over 10 years’ experience in fast paced / high volume automotive manufacturing and 8 years in medical devices• Excellent knowledge of manufacturing processes (die-casting, stamping, injection molding, machining, metal forming, welding, forging, etc.)• ISO 14971 Medical Device Risk Management (DFMEA, PFMEA, SFMEA).• Led & supported 21 CFR Part 820 included Design and Documents Control, Production and Process Controls, Corrective and Preventive actions and Nonconforming Activities.• Experienced in implementation and maintenance of ISO13485, ISO9000, QS9000, TS16949 and ISO14000 environments.• Supported and performed IQ, OQ and PQ (Installation, Operation and Performance Qualification)• Led Supplier Quality-Purchasing remediation activities at Philips Healthcare supported 100 DHF files for design control.• Led and resolved FDA Concerns in Supplier Quality/Manufacturing. Engineering include BOM, Routers and Inspection sheets (GMP).• Supported and resolved daily production issues with Internal/External Suppliers and followed Quality System Regulations (21CFR part 820.20 (Management responsibility) & 820.22(Quality Audit)• Successfully completed more than 80 DHF remediation projects for Zimmer-Knees per FDA requirements• Audit training for Supplier Evaluation and Assessment (SEAT) EXPERT-Certification completed in Philips Medical Device Healthcare (Cleveland-OH).Automotive Experience Highlights:• Successful leader leading multiple projects improving products, processes, quality, and services in growth-oriented organizations• Led new production launches and Quality Improvement at Ford, GM, Healthcare/Medical devices• DFFS (Design for Six Sigma) Green Belt Certification completed in General Motor.• Six Sigma Black Belt (PFMEA) Certification completed in General Motor.• Formally trained in DFMEA & PFMEA, Control Plan and Internal/External Supplier Audits (Onside)• Capacity Verification R@R Green Belt Certification completed in General Motor.• My QE activities include Control Charts and assigning CTQs, CAPAs and SCAR.• Quality Improvement Program Management and Production Quality Management roles• Effected the cost savings of approximately $1 million dollars for General Motor’s while in my SQE
Wkhs
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Sr. Supplier Quality EngineerWkhsDearborn, Mi, Us
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Supplier Integration EngineerTesla Fremont-Ca Feb 2024 - Present• Planning, organizing, directing, and conducting industrialization related activities within the supply chain team.• Developing and managing, auditing, improving and correcting supplier planning and execution of component manufacturing and assembly techniques and quality control processes from the advanced development phase to mass production qualification.• Providing leadership for New Product Introduction (NPI) at Suppliers; Leading supplier improvements in scalability, cost, and quality.• Facilitating communication and clarification of technical requirements between Suppliers and Tesla Purchasing, Quality, and Design teams.• Accountable for supplier audits to ensure their ability to meet part performance, delivery, and reliability expectations• Collaborating with Tesla Design, Quality, and Manufacturing to determine the ideal performance specifications and supplier metrics.• Accountable for leading, tracking and improving supplier manufacturing process development and launch readiness for new products and design changes.• Capacity and Run@Rate verification at supplier sides.
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Sr. Supplier Quality EngineerWh Feb 2023 - Dec 2023• Owned Supplier Management and Quality Systems• Supported UC-WH's Assembly Plants for materials and approved PPAP onsite with Capacity Verification and Run @ Rate.• Reviewed/Approved onsite supplier processes. • Completed more than 300 PPAP in 2022 years.• Responsible for new launches of Workhorse Products• Reviewed current models, launch Issues and 8D corrective actions/lessons learned• Reviewed High Impact Tier-2 supplier Issues with Tier-1 suppliers• Followed up on Critical issues and Containment action plans onsite• Reviewed Capacity verification and manufacturing process capabilities• Followed up on CP and PFMEA for systematic root cause Issues• Applied mistake proofing (Poke Yoke) techniques to eliminate errors and control repetitive tasks• Involved suppliers & sub-suppliers to find root causes
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Sr.Supplier Quality EngineerAbbott Jan 2022 - Feb 2023Abbott Park, Illinois, Us• Worked with the Structural Heart team to support RIP (Receiving Inspection Plan) with the Remediation team and resolving CAPA issues.• Updated drawings and changes per RIP procedure, making draft notes, and providing feedback to Engineering for these changes.• Updated CQP (Critical Quality Plan) for all risk categories of parts.• Created CO (Change Order) for RIP, CQP and other concerns.• Operations support and design control for all Production floor and related components in OEM (Original Equipment Manufacturer).• Using Iron Mountain to verifying Supplier Inspection reports/documents provided to RI including COC.• Updating First Article Inspection.• Supporting Design Control and Risk Control Documents (DFMEA, PFMEA).• Resolving Non-Conformance, SCAR issues. -
Supplier Quality EngineerStryker Nov 2020 - Dec 2022Kalamazoo, Mi, Us• New product launch (Orion Program).• Operations support and design control Production for all Production floor and related components in OEM (Original Equipment Manufacture).• Control Plan/PFMEA/DFMEA and Risk assessment activities• Worked with Design Control and Risk Control Documents• Provided leadership and supported production• Medical Device regulation (ISO 13485, 21 CFR) and Risk management (ISO 14971 Medical device risk management)• Evaluated suppliers and qualification activities per established procedures• Suppliers process approval and added to supplier list.• Provided Plant Quality Support and launch activities. -
Sr.Supplier Quality EngineerGeneral Motors, Warren, Mi Jun 2016 - Aug 2020• Supported GM’s Assembly Plants for materials and approved PPAP onsite with Capacity Verification and Run @ Rate• Owned Supplier Management and Quality Systems• Reviewed/Approved onsite supplier processes in metal stamping, casting, and forging • Motor City Stamping was my major supplier for Stamping’s parts and completed more than 300 PPAP in 4 years.• Sodecia USA/Canada was also my major supplier in Metal stamping.• Responsible for new launches of GM Products• Reviewed current models, launch Issues and 8D corrective actions/lessons learned• Coordinated Incoming Quality Department programs with PPAP, FMEA, DOE and SPC, strongly supporting production and manufacturing and resolved customer quality issues (8Ds, Poke-Yoke)• Approved PPAP for tool transfer parts from location A to B under BTAB process• Applied mistake proofing (Poke Yoke) techniques to eliminate errors and control repetitive tasks• Followed up on Critical issues and Containment action plans onsite• Reviewed Capacity verification and manufacturing process capabilities• Followed up on CP and PFMEA for systematic root cause Issues• Worked with Validation engineers if DVP required; worked closely with Product Design Engineers and resolved supplier and Internal design issues.
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Sr. Manufacturing EngineerZimmer Biomet Oem (Original Equipment Manufacturer), Warsaw, In Feb 2014 - May 2016• Operations support and design control Production for all Production floor and related components in OEM (Original Equipment Manufacture).• Responsible for MIS, work instruction sheets and CMS (change manufacturing system) • Control Plan/PFMEA/DFMEA and Risk assessment activities• Worked with Design Control and Risk Control Documents• Product/Process Validation documents/projects including IQ/OQ/PQ verification• Provided leadership and supported production• Used Medical Device regulation (ISO 13485, 21 CFR) and Risk management (ISO 14971)• Used SPC techniques for Process Capability in process variations• Utilized 6 sigma methodology and continuous improvement• Responsible for drawings, GD&T and Product/Process Controls to support Production• Supported Trauma Production Operation• Led Scrap Trending Project• Handled Warranty issues and performed root cause analysis• Led and resolved NCRs (non-conformance product) to move orders to next operation• Reviewed Warranty and Supplier Quality Issues with team members• Supported Mfg. Remediation issues• Led and provided support to 10 different Engineering teams• Resolved CAPA and Validation Gap issues• Handled Design Transfer Checklist documents to support remediation files• Provided routing and bill of materials support• Supported Mfg. transfer files to Engineering teams• Also supported and performed supplier audits in Global Supplier Quality Department• Authorized “Lead Auditor” to conduct supplier audits for Internal/External Suppliers
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Sr.Mfg Quality EngineerJohnson’S Control-Chrysler Group/Monroe-Mi May 2013 - Jan 2014• Supported Chrysler KL-2014 Launch –Jeep Cherokee• GD&T Mean Shift Calculations to target SPC = 1.67• Proposed new GD&T values to Product Design Engineering to modify engineering drawings• Calculated GD&T for more than 50 major IP components approved by Chrysler Engineers.• Chrysler Mean shift data analysis for Part Variation; set the Tolerance/Mean shift calculations• Resolved PDR and support Launch issues• Performed PPAP and APQP
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Supplier Quality /Development EngineerPhilips Mar 2011 - Apr 2013Amsterdam, Noord-Holland, Nl• Major components, are PCB (Printed Circuit board), Cameras, Temperature monitor, Heart rate and oxygen monitors• MRI machine components (X-rays images, Superconducting coils and magnet.• Evaluated suppliers and qualification activities per established procedures• Suppliers process approval and added to supplier list• Implemented of IQ, OQ and PQ to validate equipment protocol• Hands on experience to resolve issues at supplier sites• Reviewed Control Plan, Process flow and work instructions for each specific job• Approved APQP and PPA • DFMEA and PFMEA development for Critical Parts category 1 & 2• Risk assessment for supplier’s W & X category parts• GD & T reviewed for design concerns and quality defective/repetitive issues• Performed supplier oversight, monitoring and supplier audits• Created, tracked, and closed SCAR’s• Implemented new PPAP procedure and rollout to supply base per FDA findings• Formally trained employees and supply base on new procedures• Developed part requirements with NPI teams• Drove process and quality improvements with Philips team• Partnered with plant quality and regulatory to define/implement/close CAPA plans• Interfaced with Quality call to Action team• Led SQE transfers to China• FDA remediation team for support of 21 CFR Part 820• Completed more than 150 Trainings in class & Online for Job Requirements
S Umar Education Details
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University Of TorontoComputer Integrated Manufacturing. -
Ned University Of Engineering And TechnologyMechanical Engineering
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University Of TorontoMechanical Engineering
Frequently Asked Questions about S Umar
What company does S Umar work for?
S Umar works for Wkhs
What is S Umar's role at the current company?
S Umar's current role is Sr. Supplier Quality Engineer.
What schools did S Umar attend?
S Umar attended University Of Toronto, Ned University Of Engineering And Technology, University Of Toronto.
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