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Clinical Quality Specialist - Delhi

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Clinical
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190001BG Requisition #
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Clinical Quality Specialist

 

 

Careers that Change Lives

 

The Clinical Quality Specialist is responsible for assuring that clinical personnel across Medtronic are educated in, and operating within, U.S. and international regulatory requirements and standards, Medtronic standards, and facilitating continuous improvements to processes and procedures.

 

The Clinical Quality Specialist works under general supervision, following established procedures, and provides solutions to a variety of compliance problems of moderate scope and complexity.  Work is reviewed for soundness of judgment and overall adequacy.

 

 

A Day in the Life

 

·         Follow all work/quality procedures to ensure quality system compliance and high quality work

·         Provide review of clinical quality system policies and procedures aligned with relevant global regulations and standards

·         Helps Identify opportunities for clinical quality process improvement initiatives

·         Partners with superiors to ensure escalation of compliance issues to management and/or the business unit as applicable

·         Assists staff in gathering and reporting CAPA metrics

·         Assists in tracking performance measurements

·         May provide consultation to CAPA owners to facilitate identifying root cause and development of appropriate action plans

·         May act as an advisor on clinical quality assurance issues regarding various aspects of the clinical study phases (e.g. patient informed consent forms, investigational plans and amendments)

·         May partner with Clinical Quality Training Specialists to facilitate Good Clinical Practices (GCP) training for Medtronic personnel

·         May assist with department SOP/compliance training for Medtronic personnel

·         Assists department personnel with documenting compliance issues such as SOP deviations and CAPA responses

·         Participates in process improvement initiatives


Must Have – Minimum Requirements

 

·         Bachelor’s degree (technical or non-technical)

 

·         2 years experience (no experience with a M.S. degree) directly supporting clinical research within a regulated environment, or other relevant quality experience in a regulated environment.

·         Knowledge and experience of international regulations (e.g., CFDA Order No. 25, India MDR, ISO 13485, ISO 14155) and/or experience in Quality System regulations.Deep knowledge on the local culture and language

 

Nice to Have

 

·         Knowledge of ISO 14971 and other international regulatory agency requirements.

 

·         High attention to detail and accuracy

 

·         Able to manage multiple tasks

 

·         Strong interpersonal skills, ability to work with teams and be a self-initiator

 

 

PHYSICAL REQUIREMENTS:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.

 

ABOUT MEDTRONIC

 

Together, we can change healthcare worldwide.  At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday.  It is what makes this an exciting and rewarding place to be.


We can accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team.  Let’s work together to address universal healthcare needs and improve patients’ lives.  Help us shape the future.


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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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