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 OVERVIEW
BD is seeking a Quality Assurance Engineer II to join our team. In this role, you will play a crucial part in ensuring the quality and compliance of our products and processes. You will collaborate with cross-functional teams to review, approve, and close work orders, support calibration and maintenance activities, and perform equipment and process validation studies. Your expertise and attention to detail will contribute to our mission of advancing the world of health.
REQUIREMENTS
- Review, approve, and close all work orders by working with the Metrology and Instrumentation Department to comply with site calibration and maintenance standard operating procedures (SOPs).
- Strong proficiency in using Calibration, Maintenance, and Out Of Tolerance (OOT) management systems like BMRAM or equivalent laboratory equipment management systems.
- Support the facilities/Calibration department with daily, weekly, and monthly work orders.
- Generate and review OOT records, assess their impact, document risk assessments, and ensure timely closure to meet site and company quality metrics.
- Monitor the monthly workload for department assignments to ensure compliance with established service level agreements.
- Generate monthly quality equipment calibration and maintenance data to support the site’s Quality Management System (QMS).
- Review and approve completed records within the Life Cycle System maintenance database.
- Support site and department daily activities as a quality approver and coordinator.
- Review and support Internal and External audits for all calibration, maintenance, and OOT records to comply with ISO 13485, ISO 9001, and FDA regulations.
- Provide input to the Calibration and Equipment Maintenance Manager on developing and implementing a comprehensive quality calibration program, including instrumentation budget, adherence to department metrics, equipment service-related contracts, and equipment reliability and regulatory compliance.
- Support routine monitoring of the Equipment Life Cycle Management Program and provide input to the daily activities for the Instrumentation team.
- Develop a coordinated support strategy to support the business and balance competing priorities.
- Perform equipment and process validation studies, including writing, executing, and/or reviewing protocols, reports, data analysis, and deviations for new, existing, and site relocation activities.
- Author and execute Installation, Operational, and Performance qualifications for analytical and manufacturing equipment.
- Support facility and controlled non-classified environmental manufacturing area validation and qualification of GMP equipment and functions throughout the facility.
- Review and update FMEA or Risk documents as needed for validation activities for the site.
- Perform additional duties to ensure business continuity and support site and business needs.
EDUCATION
Bachelor’s degree in a relevant field such as Engineering, Science, or Quality Assurance is required.
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