Quality Engineer at Becton Dickinson NA in Carol Stream, Illinois

Job Description:

Job Description Summary




Job Description



We are the makers of possible


BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.


We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.



Position Summary

The Quality Engineer will be responsible for developing and implementing quality management systems (QMS) to ensure compliance with domestic and international regulations, standards and laws. The QE will lead and support internal audits of existing processes to evaluate conformance with ISO requirements, ensure proper documentation and maintenance of the quality system, and drive continuous improvement activities through trend analysis and root cause investigations. This position reports directly to the Manager of Quality Assurance & Regulatory Affairs.



Responsibilities

• Develop, implement and maintain a comprehensive QMS in accordance with ISO standards


• Lead and coordinate internal audits to assess adherence to ISO requirements


• Conduct risk assessments and establish quality objectives


• Monitor key performance indicators and perform trend analyses to identify areas for improvement


• Investigate root causes of defects and develop corrective action plans


• Collaborate with cross-functional teams to resolve quality issues


• Support external audits by regulatory agencies and customers


• Maintain records of all quality processes and procedures


• Continuously improve products and processes through continuous improvement initiatives


• Stay updated on industry best practices and emerging technologies related to quality engineering

Minimum Qualifications

• Bachelor's degree in Engineering or Life Sciences preferred; equivalent experience may substitute for education requirement


• Experience in quality engineering within medical device manufacturing environment


• Proficiency in ISO 9001, ISO 14001 and/or other relevant standards


• Knowledge of quality control principles, statistical process control methods and tools


• Strong analytical skills with ability to interpret data and draw meaningful conclusions


• Excellent communication and interpersonal abilities


• Ability to work effectively both independently and as part of a team


• Proven problem solving skills and attention to detail


• Previous experience leading internal audits and managing CAPA systems


• Familiarity with FDA regulations and GMP guidelines

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.



Why Join Us?



A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.


To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.


To learn more about BD visit https://bd.com/careers


Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.


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Primary Work Location

USA IL - Carol Stream



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