Quality System Specialist II – Document and Data Management
BDAbout the role
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.
As directed by the Quality Manager, the Quality System Specialist II is accountable for support of the continued development, improvement and implementation of the Quality Systems as well as maintaining compliance with regulations, standards, and Corporate requirements. This position is responsible for the coordination and management of the document control and change management process and related systems, including ACR – Assessment of Change Request, ECM – Engineering Change Management, and DMS - Document Management System. The Quality System Specialist II is the subject matter expert in these areas and has the local responsibility for ensuring complete and consistent implementation of changes.
Responsibilities
As the Engineering Change Coordinator
Responsible for governance of the change management process to ensure accuracy, efficiency, and compliance. Works with project leaders and team members to determine change implementation strategies (ECR/O
Engineering Change Request/ Order) and to identify/ collect controlled documents and SAP master data objects that will be impacted by proposed changes. Ensures that change packages are complete for release/ implementation according to ECR strategy and system requirements. Manages workflow tasks and verifies that appropriate individuals are assigned to tasks in the ECR/O process.
Develops and delivers training to associates on Engineering change management and document management topics and provides guidance and support to end users, including system troubleshooting and issue escalation.
Responsible for identifying and implementing improvements to the overall document control and change management process.
Responsible for the quality and accuracy of the Quality records including document security.
Responsible for management of the C2C (Compliance to Capability) Learning Management System. This includes maintenance of training records and curriculum related to Quality System and SAP. As the SAP access request Super User, is responsible for administration of new role requests in SAP.
Minimum Requirement:
Degree level qualification; or equivalent combination of education and experience.
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.
PDN
Primary Work Location
USA NJ - Franklin LakesAdditional Locations
Work Shift
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