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.
Job Position Title: Quality Systems Engineer
Function: Quality
Location: Columbus NAMc
Job Group/Grade: JG3
Position Summary:
Support Quality and Production groups by using process and regulatory knowledge combined with a data driven approach to problem solving. Become a subject matter expert in application of statistical tools, measurement systems analysis, and root cause analysis. Take ownership of projects and drive to completion, whether working independently or in a team. Will interact professionally with customers in project management and problem-solving activities. Ensures compliance with BD quality systems, policies, procedures and best practices, and all local, state, federal and BD safety regulations, policies and procedures. Regular, punctual attendance is an essential job function. Ability to read and write and converse in English. Willing and able to uphold BD Values.
Duties/Responsibilities:

Responsibilities include but are not limited to:

• Oversees Quality Audit, Supplier Quality, and Environmental monitoring programs.
• Coordinate plant and supplier activities associated with implementation and maintenance of robust supplier quality programs including audit programs.
• Monitor and track metrics, which are aligned with the quality of incoming components/products from suppliers.
• Provides assistance with hosting customer audits, maintaining minutes, generating reports for customers and tracking actions through completion.
• Maintain metrics for the quality systems and perform data review which may lead to CAPA.
• Analyze and report environmental conditions for various manufacturing operations.
• Assist and/or manage plant projects and drive to completion.
• Participate in audits as process and quality systems.
• Develop Root cause investigation and CAPA experience.
• Develop an understanding of the validation system and assist in validations.
• Conduct Measurement System Analysis.
• Conduct diagnostic and statistical analysis of methods, equipment and materials to improve product quality, process reliability and cost.
• Assist in meeting plant team plans for cost and quality improvement, operating within department budget guidelines.
• Demonstrate ability to make consistent and data driven decisions.
• Other duties as required to support the needs of the business.
• Completion of projects on time and on budget.
• Complete investigations and validations.
• Maintain environmental monitoring program.
• Maintain ISO 13485 Certification.
• Robust quality supplier program.
• Continuous improvement of incoming quality.

• Oversees Quality Audit, Supplier Quality, and Environmental monitoring programs.
• Coordinate plant and supplier activities associated with implementation and maintenance of robust supplier quality programs including audit programs.
• Monitor and track metrics, which are aligned with the quality of incoming components/products from suppliers.
• Provides assistance with hosting customer audits, maintaining minutes, generating reports for customers and tracking actions through completion.
• Maintain metrics for the quality systems and perform data review which may lead to CAPA.
• Analyze and report environmental conditions for various manufacturing operations.
• Assist and/or manage plant projects and drive to completion.
• Participate in audits as process and quality systems.
• Develop Root cause investigation and CAPA experience.
• Develop an understanding of the validation system and assist in validations.
• Conduct Measurement System Analysis.
• Conduct diagnostic and statistical analysis of methods, equipment and materials to improve product quality, process reliability and cost.
• Assist in meeting plant team plans for cost and quality improvement, operating within department budget guidelines.
• Demonstrate ability to make consistent and data driven decisions.
• Other duties as required to support the needs of the business.
• Completion of projects on time and on budget.
• Complete investigations and validations.
• Maintain environmental monitoring program.
• Maintain ISO 13485 Certification.
• Robust quality supplier program.
• Continuous improvement of incoming quality