Muhammad Asfar

Results-driven Compliance Manager with specialized experience in EU MDR 2017/745 and ISO 13485:2016 quality management systems. Proven track record in leading successful amfori BSCI social audits and managing end-to-end regulatory documentation for medical device manufacturing. Currently pursuing a Bachelor of Science in Information Technology, leveraging a technical background to optimize ERP systems, ensure data integrity, and streamline digital compliance reporting.

Seeking to leverage expertise in EU MDR 2017/745, ISO 13485 and ISO 9001 to support global Post-Market Surveillance and Vigilance operations.

Quality Management System (QMS) & MDR Compliance at Kotsteel Pvt Ltd (2023-09 – Present)

• Managed daily Quality Management System (QMS) operations in accordance with ISO 13485:2016, ensuring all manufacturing processes remained compliant with EU MDR 2017/745 requirements
• Coordinated with internal production teams to monitor Quality Key Performance Indicators (KPIs) and utilized Root Cause Analysis to resolve non-conformities and operational issues
• Maintained rigorous Device History Records (DHR) and Quality Records in accordance with ISO 13485 ensuring 100% data integrity for international audits
• Assisted in the preparation of Post-Market Surveillance (PMS) data and monitored production-level feedback to support continuous safety and performance reporting
• Implemented Continuous Improvement (CAPA) strategies to increase manufacturing efficiency while maintaining strict adherence to safety and performance standards

Social Compliance & amfori BSCI at Kotsteel Pvt Ltd (2023-09 – Present)

• Ensured 100% compliance with amfori BSCI Code of Conduct and local labor regulations, focusing on fair remuneration, occupational health and safety (OHS), and ethical business behaviour
• Managed comprehensive employee records and HR documentation to ensure successful outcomes during amfori BSCI social audits
• Supervised recruitment and onboarding processes to ensure they met international standards for social responsibility and non-discrimination
• Handled payroll coordination and leave management systems with a focus on transparency and regulatory accuracy, as required for social compliance verification

In-charge ERP (Operators) at Leather Field Sialkot (2022-06 – 2023-06)

• Supervised ERP operators and ensured accurate system data entry
• Monitored ERP transactions related to inventory, HR, and operations
• Verified data accuracy and resolved system or entry-level errors
• Generated ERP reports for management review and decision-making
• Coordinated with departments to ensure smooth ERP system operations
• Trained and supported ERP operators on system procedures

Bachelor of Science in Information Technology – Virtual University of Pakistan (2022-2027) ICS – Quaid-e-Azam Higher Secondary School (2020-10 – 2022-10) Matriculation – Govt Awami High School (2018-04 – 2020-09)