Blanca Morales

Blanca Morales role is not a very easy role within the Medtronic Restorative Therapies Group (RTG). If a Medtronic device fails in or out of the field. It is Blanca Morale’s and her team’s job to find the underlying cause of the failure. If a device fails in house during a product development phase, Blanca and the R&D Manager sit down and discuss and develop a timeline suitable to pinpoint the issue and correct the problem. As a Senior Quality Systems Specialist, Blanca Morales played a key role in developing new quality protocols that improved and surpassed existing quality protocols for the development of the Medtronic Plasma Blade. Her influence and leadership skills in Quality Improvement project completion and presentation helped move

Her role as a Principal Quality Systems Specialist is to ensure that Medtronic as a medical device company follows and operates under strict internal company standard operating procedures, but also follow every applicable FDA, HIPPA, and CMC law applicable to health care organizations and medical device companies. When a product fails in the field or worse, the product fails in the field and a patient is injured due to the product’s failure. Blanca Morales and her team must try to obtain sensitive incident product and patient information. When a patient is reported to have been injured by a Medtronic RTG product in the field, the first question that must be asked is, “How bad was the injury to the patient?” The second question is, “Has all of the relevant patient and product information been gathered to take corrective actions?” As a Principal Quality Systems Specialist, Blanca Morales must ensure that all federal and internal processes are followed in obtaining and distributing of Patient Electronic Health Records pertinent to the product failure. Blanca Morales must make sure that patient and product information distribution and use must follow HIPPA privacy guidelines and internal patient Health Information standard operating procedures. Following HIPPA guidelines is only one example of the impact federal guidelines have on quality improvement initiatives that Blanca Morales provided. Blanca kindly said that as a medical device company operating within the United

The most important career developing skill that I took from interviewing Blanca Morales is that every decision that we make has the potential to impact someone’s life in the future. Knowing that every action might impact an individual is a good driving force to always perform our job responsibilities to the best of our abilities. The margin for error where an individual is not impacted by not following internal and external quality guidelines is extremely minimal. Do everything to the best of our abilities and providing the best possible product for our patients is the only way to operate as a medical device company. As medical device company employees, our duty is to the betterment of patient lives while following federal guidelines. The most important aspect that I will take from interviewing Blanca Morales in my professional development is that quality is measured on how well patient’s quality of life is changed by a Medtronic product not by how much product is sold and how much revenue is