Job Description Summary

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.

The Senior Director Quality Auditing/Systems reports to the VP Quality Management or assisting in managing the development, implementation, and improvement of an effective quality system designed to meet appropriate Business, Segment, Corporate, Government, and International Standards for efficacy, safety, and quality. The Sr Director Quality Auditing/Systems is responsible for standardized and where appropriate, unified deployment of quality processes across the World-Wide Integrated Diagnostic Solutions (IDS) business. Assures programs are consistent in complying with FDA Quality System Regulation, ISO 13485, and ISO 9000 (and similar) standards for IVD and Medical Device products in both clinical and industrial applications as well as custom products. Works on complex problems where analysis of situations or data requires an evaluation of intangible, variable factors. Exercises judgment in developing methods, techniques, and evaluation criteria for obtaining results. Ensures that budgets and schedules meet BD IDS targets or that changes are approved at appropriate levels.

• Functions as the Management Representative for the quality management system.
• Develops Business Unit Management Review presentation and follow-up on action items; includes collecting and evaluating metrics; and providing required information for the Executive Management Review
• Maintains Quality and KDG metrics across Integrated Diagnostic Solutions, including developing e-solutions.
• Manages and coordinates the Quality Systems staff who exercise responsibility for results in terms of compliance, costs, methods, and employees.
• Establishes and delegates operational goals, objectives, and assignments. Formulates and implements policies and procedures to carry out IDS quality policy in support of the BDX policy on a worldwide basis.
• Develops and implements quality information reporting systems and administers FDA, ISO 13485, ISO 9000, MDSAP, MDR / IVDR and Japanese PAL standards including audits, certification, and the Management Review process.
• Promotes, develops, and manages continuous quality improvement activities through effective utilization of the CAPA system as well direct involvement in all situation analysis processes.
• Hosts external regulatory inspections. Ensures that pre- and post-inspection activities are completed including scheduling, record review, training, logistics, etc. Prepares responses to audit nonconformities for review by senior management.
• Ensures adequate and effective auditing of IDS quality systems. Organizes audits on a timely basis to ensure compliance with appropriate standards and regulations for the development, manufacture, release, and support of all IDS products. Assists in development of corrective and preventive action when appropriate. Ensures effective reporting mechanisms are developed and followed at IDS. Ensures MDR, Vigilance and Canadian reporting requirements are understood and met. Establishes clear policy for complaint reporting within IDS. Ensures timely submission of product related reports, documentation, or communication to responsible IDS and Corporate departments.
• Responsible for management of Document Control, CAPA, and Training and is ultimately accountable for the adequacy and proper controls of the processes
• Responsible for developing a compliant and efficient Change Control process, including e-solutions.
• Leads Supplier Management activities for IDS. Includes maintaining all OEM suppliers, supplier policies and procedures and interfaces with Corporate Supplier Management Director.
• Develops and monitors budgets for capital expenditures, operating supplies, and labor. Provides justification for resource requirements to senior management.
• Communicates project status, compliance progress, problems, and procedures across all applicable IDS groups.
• Carries out Human Resource management responsibilities such as hires, job assignments, coaching, termination recommendations, transfers, promotions, salary actions, and processes performance reviews on time.
• Exercises responsibility for associate training, development, and motivating supervised associates.
• Keeps abreast of the U.S. and non-U.S. regulations affecting own area of supervision/management and complies with those regulations. Initiates changes to IDS practices and procedures to support compliance requirements. Communicates the need for compliance to members of own functional area. Brings quality compliance questions/issues to the attention of the next level of management.
• Develops, documents, administers, and maintains Quality Systems for conformance to regulatory requirements and company policies.
• Develops and provides quality system training for the IDS organization WW.
• Partners with other quality professionals to address recurring issues identified throughout the organization.
• Performs all other duties and supports projects as assigned.

• Typically requires a BS in a related scientific or engineering discipline and 8 years' experience in Quality, Regulatory, or Operations of a Medical Device firm.
• Professional certification is an advantage (i.e., CQA, CQE, SQE, CQM, Etc.

• Thorough knowledge of quality systems regulations. (ISO; FDA; MDSAP)
• Effective communication skills at all levels both written and verbal.
• Effective financial management, planning, and organizational skills.
• Demonstrated ability to motivate and manage exempt and non-exempt level Quality Systems personnel.
• Effective analytical, technical, and problem-solving skills.
• Effective meeting and presentation skills.
• Ability to perform multiple tasks and prioritize workload
• Effectively manage conflict.
• Ability to work in or direct teams to obtain results