Amina Khan

I'm an Innovative & perceptive experienced Quality engineer equipped with academic knowledge, rich, extensive and progressive experience of 06 years across functional areas. Experience leading quality audits, in particular with regards to IEC 62304 and IEC 62366 IEC62304, f ISO13485, 21 CFR 820, ISO 13485, QSR, ISO 14971, ISO 9001, ISO 14001, ISO 45001 and ISO 50001 standards and other international standards, Implementation and maintenance of the Corporate Directorates ISO 9001 Management System, in specific in the Facilities Management Department of a well-known health care industry. Expert in maintenance and operations of a wide spectrum of medical equipment and systems. Enriched with expertise of preventive and breakdown maintenance of various equipment. Possesses eminent technical reporting & communication skills of a tertiary care hospital. 

• Preparing the technical specifications on the basis of recommendations from clinical staff to procure most updated, cost effective and best performing equipment. 
• Supervised and monitored the installation and commissioning of life saving biomedical equipment of the critical care areas.
• Prepare and conduct internal and 2nd party quality audits in the Facility Management & safety.
• Conducted risk assessments & prepared KPIs to monitor the performance of various areas & support QMS management review 

• Efficiently keeping preventive maintenance schedule and calibration schedule for medical equipment and keeping downtime to minimum.
• Coordinating with OEM and commissioning team to provide feedback regarding installed equipment to improve the user experience.
• Keeping a close coordination with the international bodies and conducting trainings for the clinical staff on Equipment Operations.
• Devising/ reviewing the policies and procedures to improve services related to medical equipment.
• Preparation of PPM Plans, and its execution and monitoring in compliance with OEM instructions.
• Liaison with Quality Assurance Department for the Internal and External Audits.
• Supervising the Complaint Management System of Biomedical Department.
• Keeping the Inventory record all medical equipment and analyze the needs of respective departments to ensure quality services.
• Compiling minute of meetings held internally and externally executing agencies.
• Taking follow ups on the completion of works as per given timelines.

• BSc Biomedical Engineering - Riphah International University Islamabad (2017).

Majors:

• Electrophysiology & Human Anatomy
• Health care & Safety.
• Quality management.
• Instrumentation and Imaging.