Iravati Ambike

Supporting the Shockwave IVL and RBU production line. Sustaining production support and post market investigation

Responsible for CAPA Management, Internal and External Audit Management, Change Management and Document Control, Quality Systems Training, Labeling. Complaints Invesitgation

As a part of Quality Trust and Compliance (QTC), responsible for the below: • Administration of the eQMS, including the development and revision of controlled documents • Administration of training materials for all endpoint departments and serving as a quality and regulatory compliance subject matter expert for training execution • Working closely with internal departments to assure training compliance with internal quality systems and regulations issued by the Food and Drug Administration (FDA), and other applicable regulatory bodies • Representing QTC for client audit meetings • Identifying and documenting process deviations, non-conformances and following up until required corrective and preventive actions are performed • Ensuring required aspects of the endpoint eQMS and endpoint Training Management System are trended on a routine basis for presentation to Quality, Trust, and Compliance (QTC) Management for review

• Conducted site qualifications, initiation, monitoring, and close out visits in compliance to ICH-GCP, Medpace/Sponsor SOPs, and applicable regulatory requirements • Responsible for overall site management for assigned sites, including communication with surgeons and applicable site staff • Responsible for quality assurance of data and ensuring good documentation practices

Medical device company developing a Totally Artificial Heart (TAH) system • Set up 2 robust in vitro verification testing rigs to simulate hemodynamic pressures and flow rates for systemic circulation in varying levels of heart failure - Managed project from initial stages which involved purchasing materials, vendor management, assembly of 400 components by application of mechanical and electrical engineering skills, testing and quality assurance, drafting assembly and operation protocol until international shipping to final location • Maintained and recorded critical parameters for different TAH prototypes to establish device durability • Designed and constructed a modified hanging test loop to propel blood analogue in the TAH for more accurate recordings and to facilitate easier data collection Other tasks- Inventory and budget management, vendor relationships.

- Grading homework, assignments, quizzes as required. -Assist in the Bioengineering Department office with grading, filing, copying, paperwork, answering phones, and other projects as assigned.

Detoxification of teeth and titanium dental implants

Responsibilities include- --Checking library materials in/out of the library; --Assist with copy/printing/ scanning equipment; --Respond to users' questions and provide accurate information; --Assist in collection maintenance by shelving materials, moving/shifting the collection as needed, --Search for lost/missing materials, and read the shelves to ensure that items are in the proper order. --Other library duties as assigned.