Quality System Specialist

Job Description Summary

The Quality System Specialist, Digital Quality - Solution Delivery & Integration will play a key role in advancing, maintaining, and optimizing the digital solutions supporting the organization's Quality Management Systems (QMS). This position is responsible for ensuring system reliability, regulatory compliance, and continuous improvement across quality processes and digital platforms. The associate will partner closely with Global Process Owners, Technology & Global Services, and cross-functional teams to translate business requirements into system capabilities, resolve user issues, support system validation activities, and drive enhancements that improve efficiency and user experience.

This role requires strong analytical and problem-solving skills, deep knowledge of regulated quality systems, and the ability to support both operational needs and strategic quality initiatives.

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 Med Tech 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 Responsibilities:

Primary Responsibilities:

* Support end users with process and system usage related questions; this includes partnering with TGS (Technology & Global Services) 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.

Education and Experience:

* 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).

Knowledge and

Skills:

* 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 Pega, Track Wise, Power BI, AI, Product Holds, Change Control, Complaint Management, CAPA, Field Actions, Audit Programs.

Work Environment:

* Willing to travel when required.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of…