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 are committed to a promising future by developing innovative technologies, services, and solutions that help the healthcare community improve safety and efficiency. It takes the imagination and passion of all of us at bd, from manufacturing to marketing, to look at the impossible and find transformative solutions—turning 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 to the acceptance of medical devices, such as inspections, methods, and validations. They constantly evaluate processes to improve and reduce potential risks that could adversely affect products or patients, or pose compliance risks. They coordinate activities to evaluate internal and external trends, deviations from the intended use of the product, and generate action plans to address such failures. Using a risk-based approach, they verify compliance of internal processes, discrepant materials, and reports from external sources such as customers and healthcare personnel, acting accordingly. They also support activities related to transferring new products/processes to the facility and develop the necessary documentation and tests for in-process verification to accept the product.
minimum qualifications
* bachelor’s degree in engineering, biomedical, biochemistry, chemistry, medical, or biological sciences.
* at least 5 years of experience in a decision-making engineering role or equivalent.
* experience in the medical industry with a quality assurance position.
* experience in an fda-regulated industry is preferred.
* asq certification in quality engineering areas is preferred.
* language skills: upper intermediate.
additional information
bd values equity in the workplace without discrimination based on disability, class, ethnicity, age, religion, gender identity, or sexual orientation.
job details
* primary work location: mex nogales south – parque industrial el cid
* employment type: full-time
* industry: biotechnology research, medical equipment manufacturing, research services
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