Quality System Specialist, Digital Quality – Solution Delivery & Integration

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.

Primary Responsibilities:

• Support end users with process and system usage related questions; this includes partnering with TDS (Technology & Digital Services) and or vendor on issue resolutions and communication with end users. 
• Provide on-demand user support and troubleshoot data/system issues. 
• Collaborate with Global Process Owners (GPO) to collect, interpret, and analyze business requirements to shape the design of the quality management system.  
• Identify opportunities for system improvements and lead initiatives to enhance system efficiency, user experience, and overall quality management capabilities.  
• Shape project direction and timeline and make recommendations that include alternative solutions. 
• Support validation and testing activities; this includes authoring PQ test scripts and support execution in alignment with validation protocols.  
• Ensure the system is compliant with applicable regulatory agency requirements and company policies. 
• Work closely with cross-functional teams to ensure the system meets business needs and compliance requirements. 
• Develop and deliver training programs to ensure employees are knowledgeable about quality systems, procedures, and best practices. 
• Support dashboard metrics development, ad hoc data extraction, and data analysis. 

• Bachelor's degree, preferably in Quality Management, Engineering, Life Science or Technology field. 
• Minimum of 3 years of experience in quality management systems within a regulated industry (e.g., medical devices, pharmaceuticals). 

• Excellent analytical, problem-solving, and project management skills. Strong attention to detail and ability to manage multiple priorities. 
• Exceptional written and verbal communication skills with the ability to lead and influence cross-functional teams. 
• Proficient in quality management software and tools, as well as Microsoft Office Suite. 
• Effective meeting and presentation skills. 
• Candidate must be self-motivated, self-directed, a team player, and willing to learn & adapt. 
• Preferred experience working with MasterControl, Pega, TrackWise, Power BI, AI, Document Management, Product Holds, Change Control, Complaint Management, CAPA, Field Actions, Audit Programs. 

• Willing to travel when required.
• Work in the office at a BD site.