Quality System Specialist
BDAbout the role
We are the people who give possibilities purpose
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.
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 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, TrackWise, Power BI, AI, Product Holds, Change Control, Complaint Management, CAPA, Field Actions, Audit Programs.
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