
Faraz Aamir
Intern

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About me
Medical Devices/IMS Auditor | QA/RA Specialist | MDR/MDD | FDA/GMP | ISO 13485 | ISO 9001 | ISO 45001 | NEBOSH IGC
Education

Wah Engineering College, University of Wah
2013 - 2017Bachelor’s Degree Mechatronics, Robotics, and Automation Engineering 3.27/4.00 CGPAActivities and Societies: I have participated in inter-university E-Gaming competitions and other extra-curricular events, I have also been part of team of organizers in university events.

Superior College of Science (For Boys), Sialkot
2010 - 2012F. Sc. Pre-Engineering First Division
Cathedral School No. 1 Christian Town, Sialkot
2008 - 2010Matriculation Computer Science First Division
Experience

Heavy Mechanical Complex
Aug 2016 - Sept 2016Intern-Observing manufacturing of different parts and also learning about different tests performed on them. -Raise efficiency and standards of performance of machines.-The growth of the individual in terms of ability, understanding and awareness.-Variations in the efficiency, productivity, flexibility of labor as a result of training, work study, organizational change, new motivations, etc.
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Forward Gear (Pvt.) Ltd.
Dec 2017 - Nov 2018Operations and Maintenance Engineer-Planning, organizing and executing machine preventive maintenance schedule-Inspecting parts and maintaining cost effective machine parts inventory-Automation of manual processes to increase efficiency-Training of maintenance team on performing maintenance of Automatic Printing Machines-Increased Accuracy and reduction in wastage of Hot Webbing Cutting Machines by re-calibrating their encoders. -Research on common sewing problems and implement their cost effective solution-Reduction in SMV/SAM by shifting operations to automated machines or by combining multiple operations on specialized machines-Preparing Overall Equipment Efficiency and Downtime Tracking report to assess potential bottlenecks in production Show less

VEER Sports
Nov 2018 - Sept 2019Operations and Maintenance Engineer-Developed Machine Operating and Maintenance S.O.Ps to ensure safe working of all machines -Preparing and Implementing maintenance procedure and schedule of Sewing, Accessory Preparation, Fabric Inspection, Auto Packing, Metal Detector, Auto Cutter and Printing (Screen making, Sublimation and Heat Transfer) Machines-Decreased Monthly & Seasonal Downtime by tracking and eliminating potential issues beforehand-Increased Production of Slider mounting and Zipper cutting operation by combining the operations and shifting them to Automatic Machine-Introduced Kaizen culture and continuous improvement concepts to maintenance team-Training of Machine operators on performing basic maintenance and thus decreasing potential downtime and machine breakdowns-Increased Sewing Efficiency by modifying Bartack Sewing Machines to perform multiple operations in one sewing burst-Eliminated multiple overhead operations by using Specialized Jigs on Automatic Pattern Machines-Decreased Sewing SMV/SAM by eliminating handling in multiple operations and shifting those operations to Template Based Sewing-Installation and Commissioning of Auto Packing, Auto Cutting, Laser Cutting and Digital Printing Machines. Show less

Tecno Instruments Pvt Ltd
Jan 2020 - Jun 2022QA Engineer- Analyze and improve production processes to increase production and decrease overheads- Prepare Standard Operating Procedures and Work Instructions for every process going on in all departments- Implement Quality Management System in all departments as per Medical Device Regulation (MDR) EU 2017/745 and ISO 13485 - Training of Relevant personnel on updated ISO standards and FDA regulations along with Good document practices-Customer Complaint handling, generating and implementing corrective actions for product, system and material based non-conformance along with performing change control documentation (Change Notices)-Performing Validation of critical processes by analyzing the Installation Qualifications, Operational Qualifications and Performance Qualifications for these processes.-Preparation of Technical Documentation of Products i.e. Technical Files, DMR/DHR, Technical Datasheets, IFUs and control protocols for manufacturing.-Implementing and Sustaining relevant clauses of ISO 13485: 2016 and cGMP for every product's processes-Performing and Preparing Internal Audits, Material Inspection Reports, Process validations, Equipment Calibrations, Training and Weekly/Monthly/Bi-Annual Reporting-Introducing the concept of Continuous Improvement and Kaizen culture to all departments-Acting as Management Representative when higher management isn't reachable for decisions onproduction issues Show less

Towne Brothers (Pvt) Ltd
Jul 2022 - Mar 2024Quality Assurance Manager- Supervise implementation and maintenance of Quality Management Systems for product manufacturing, control, storage, and primary distribution processes.- Ensure compliance to Quality Manual, Quality System Directives, and Quality Systems standards and regulations (FDA QSR, ISO 13485:2016, ISO 9001:2015 and MDD/MDR).- Prepare and review Technical Files, and QMS documentation submissions for Thai FDA, Saudi FDA, and Australian Register of Therapeutic Goods among others.- Maintain all International registrations and records.- Manage internal and external QMS Audit programs; ensure audit compliance and follow-up to close out audit non-conformance(s).-Maintain supplier quality management and perform supplier evaluation including qualification of suppliers, supplier corrective actions, and guiding subcontractors and component supplier audits.- Drive continuous improvement through CAPA projects, and proactively identifying and implementing best-in-class quality system practices.- Review and approve documents including manufacturing batch records in support of product release, SOPs, process validation protocols and reports, and quality agreements.- Support maintenance department and ensuring all equipment are calibrated as per standards and keeping the process consistent with annual plan.- Proactively investigate and analyze customer complaints, and oversee problem reporting to regulatory agencies as required.- Supervise and develop team members and train quality inspectors/officers for new procedures.- Trained staff in regulatory policies or procedures to introduce them to QMS culture. Show less

SGS
Mar 2024 - nowMedical Devices Auditor- Conducting and leading certification audits, identifying non-conformities and driving corrective actions- Evaluating client management systems, processes, and procedures against relevant standards, regulatory and statutory requirements- Made informed certification recommendations to the certification committee- Collaborated with clients to identify areas for improvement and implement effective corrective actions- Trained and mentored junior auditors to enhance team performance and expertise- Maintained up-to-date knowledge of relevant standards, regulations, and industry developments Show less
Licenses & Certifications

NEBOSH International General Certificate (IGC) in Occupational Health and Safety
NEBOSHJul 2025
Risk Management Basics
WMDO - World Medical Device OrganizationMay 2024
Medical Device Regulation (MDR) Technical Documentation
SGSJun 2021- View certificate

ISO 45001:2018 Occupational Health and Safety Management Systems Auditor / Lead Auditor Training Course
SGSAug 2024 - View certificate

ISO 9001:2015 - Quality Management Systems Auditor/Lead Auditor Training Course
SGSJul 2024 
ISO 14001:2015 - Environmental Management Systems Auditor/Lead Auditor Training Course
SGSSept 2025- View certificate

Registered Engineer
Pakistan Engineering CouncilJan 2018
Honors & Awards
- Awarded to Faraz AamirBronze Medalist University of Wah Nov 2017 Bronze Medalist in the batch of 2013 of Mechatronics Engineering.
- Awarded to Faraz Aamir3rd Best Senior Design Project Wah Engineering College May 2017
Languages
- enEnglish
- urUrdu
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