Openings in HCl Tech for Quality assurance compliance specialist

Openings in HCl Tech for Quality assurance compliance specialist

 About the Company 

The firm is a software and clinical dealing one and is a reputed one in India and Globally.

About the Job 

Experience required : Minimum of a Graduate Preferable – Pharmacy, Medical Instrumentation, Nursing, Bio Medical,  Education or Engineering Degree, Associate’s or bachelor’s degree preferred 

Need to have a Minimum of 3-5 years of experience with a Medical/pharma devices product life cycle
or Pharma company is preferred

Able to Receive and log the issues raised by customer in various input channel (Inbound call, E-mail, Fax, etc) and route to right team for resolution and reporting and further communication & Closure basis product segment.

Required to have exposure to software like QMS, MDR, Trackwise AER reporting and regulatory knowledge such as FDA, EMA, 21CFR820, GAMP5, GMP (Good manufacturing Practice)

Effective processing and Intake of complaints in the application and follow up for the required data for complaint intake and investigation

Able to handle and Collaborating with Clinical application specialists and Field service Engineers  and sales/marketing personnel as a part of complaint intake and further related process

Handling  complaints, customer inquiries,  and coordinating with respective team for resolution

flexible and collaborative, including willingness to work overtime as needed and/or an occasional Saturday if business needs dictate.

Reviewing the technical service records for complaint criteria and assigning risk level
 management/interacting with global stakeholders in a Technical/Non Technical voice process and Non voice

Knowledge and handling all complaints as FDA/MDR and other regulations governing medical devices regulations.

Proficiency in Microsoft Office and related tools 

Required excellent customer service skills and effective problem solving and a strong team orientation.

Ability to successfully multi-task and manage several diverse responsibilities in a timely and accurate manner.

Excellent organizational skills; attention to detail and required to be Flexible to work in night shift.

Handle inbound and outbound calls to customers and internal stakeholders and effectively Ensure the conversations with the customers are recorded in the system accurately for future references and analysis.

Timely hit the personal targets and help meet the colleagues and teams target as well and able to Ensure to follow the necessary scripts provided and no deviations.

Ability to Resolve service query or complaints to the satisfaction of the customer within established company guidelines.