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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

Responsibilities:

As the Management Representative for the Sumter Plant, (as defined per ISO 13485:2003 and 21 CFR 820).  you'll serve as the cornerstone of our quality management system, bringing quality standards to life through:

• Quality System Champion - Establishing, implementing, and maintaining vital quality management processes

• Executive Quality Liaison - Delivering insightful performance reports to top management through Management Review meetings, highlighting improvement opportunities

• Regulatory Awareness Ambassador - Fostering a culture where every team member understands and embraces regulatory and customer requirements

• Inspection Point Person - Serving as the primary contact for FDA, ISO, and third-party audits, representing the Sumter site

• Compliance Program Overseer - Managing comprehensive quality activities including CAPA, Quality Notifications, Temporary Deviations, Internal and Supplier Audits, Change Control, Calibration, and Complaint Investigations.

  • This includes compliance to applicable regulations and standards for medical devices and pharmaceutical products.

• Product Release Guardian - Supervising laboratory operations and release personnel to ensure only safe, effective products reach customers, including on-site sterilization quality oversight

  • Responsible for approval or rejection of components, finished products, and documents to achieve this purpose.

• Strategic Leadership Team Member - Contributing to the Plant Leadership Team and Executive Steering Committee to drive plant initiatives and achieve organizational goals

• Quality Strategy Architect - Developing and maintaining forward-thinking quality plans and policies that align business objectives with regulatory requirements

• Continuous Improvement Driver - Directing Quality Assurance projects through leadership teams to maintain regulatory compliance and support plant continuous improvement efforts

• Talent Developer - Building a high-performing quality team through targeted training and professional development opportunities

• Financial Steward - Managing the Quality department and laboratory budget with efficiency and foresight

• Problem-Solving Partner - Collaborating with multi-functional teams to identify root causes of quality issues and customer complaints. Works with the Design Center Quality Management to drive investigations for product issues in the field and assists with the preparation of Situation Analyses.

• Product Development Collaborator - Supporting new product initiatives and facilitating smooth Design Transfer from development to manufacturing

• Safety Compliance Advocate - Adhering to all local, state, federal, and BD safety regulations, including RCRA Hazardous waste protocols

Required Qualifications:

• BS degree in Engineering or Life Sciences

• 5 years Managerial experience in highly regulated Medical Device Plant

Preferred Qualifications:

• Master Degree in Business or Engineering

• ASQ Certification

• Six Sigma Certification

Knowledge and