- 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.- 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.

-Analyze and improve production processes to increase production and decrease overheads-Prepare Standard Operating Procedures and Operational Steps for every process going on in all departments-Implement Quality Management System in all departments-Training of Relevant personnel on updated ISO standards and FDA regulations-Implementing and Sustaining relevant clauses of ISO-13485:2016 and CGMP for every product\\\'s processes-Assist QA/QC department in performing/preparing Internal Audits, Material Inspection Reports, Process validation, Equipment Calibration, Training and Weekly/Monthly/Bi-Annual Reporting-Introducing the concept of Continuous Improvement and Kaizen to all departments-Acting as Management Representative when higher management isn\\\'t reachable for decisions on production issues

-Analyze repair reports from preventative and predictive maintenance, unscheduled downtime, and update equipment/facility work plans to ensure that repeat breakdown events are eliminated
-Deploy, train, coach, monitor resources to ensure that the required levels of quality and quantity of workmanship are followed
-Introduced Kaizen culture and continuous improvement concepts to maintenance team
-Training of Machine operators on performing basic maintenance and decreasing potential breakdowns
-Implemented CMMS and making sure that all equipment is assigned a relevant maintenance activity program according to equipment criticality ranking
-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

-Planning, organizing and executing machine preventive maintenance schedule
-Inspecting parts and maintaining cost effective machine parts inventory
-Support Continuous Improvement initiatives of the manufacturing team
-Preparing Overall Equipment Effectiveness and Downtime Tracking report to assess potential bottlenecks in production
-Training of maintenance team on performing maintenance of Automatic Sewing Machines
-Research on common sewing problems and implement their cost effective solution
-Implementation of automated assembly line & lean manufacturing processes