Job Description Summary

Job Description

How about becoming a maker of possible?
For more than 125 years, we’ve pursued our Purpose of advancing the world of health™. We relentlessly commit to a promising future by developing innovative technologies, services and solutions, helping the healthcare community improve safety and increase efficiency. It takes the imagination and passion of all of us at BD, from the manufacturing to marketing of our products, to look at the impossible and find transformative solutions to turn dreams into possibilities – For people today, tomorrow and beyond. Become a maker of possible with us!

The Senior Quality Assurance Engineer leads and supports all activities related for acceptance of medical devices, such as inspections, methods, validations, they are constantly evaluating the process to improve and reduce potential risks that could cause an adverse effect on products/patients or could pose a
compliance risk. Coordinates activities to evaluate internal and external trends at deviations from the intended use of the product and generates action plans to address such failures. By having a risk-based approach they verify compliance of internal processes, discrepant material being received, reports from external sources such as customers, healthcare personnel, intercompany, and acts accordingly. He/She provides support and feedback to activities related to new products/processes being transferred to the facility as well as to develop the required documentation and tests to perform the in-process verification to accept the product.

Finished bachelor’s degree in careers related to Engineering, Biomedical, Biochemist, Chemist, Medical and Biological.
Five (5) years of experience in a position taking decisions in engineering area preferably or equivalent.
Experience in medical industry with a quality position
Experience in an industry regulated by the Federal Drug Administration (FDA) preferably.
Certified by the American Society for Quality (ASQ) in quality engineering areas preferably.

Language Skills: Upper Intermediate

“BD values equity in the workplace without discrimination for any disability, class, ethnicity, age, religion, gender identity or sexual orientation.”

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