Associate Quality Director

Reporting to the VP of Quality Management

, the Associate Director, Plant QA leads and directly manages technical and managerial staff at the Sumter facility. This role plays a pivotal part in shaping global quality strategy and driving the tactical execution needed to achieve organizational objectives.

Through exceptional communication, proactive problem-solving, and confident navigation of ambiguity, the Associate Director ensures product safety, quality, and full compliance with global regulations and customer expectations.

Success in this role is measured by the minimization of product quality and organizational issues, as well as the continuous improvement of business process effectiveness. By fostering strong relationships with internal and external stakeholders — and investing in the growth and development of people — the Associate Director, Plant QA delivers sustainable, industry-leading results that support key business drivers.

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 Skills:

• Exhibits an exceptional degree of ingenuity, creativity, and resourcefulness
• Applies and / or develops highly advanced technologies, scientific principles, theories and concepts.(Viewed as expert within the field)
• Provides technical knowledge and expertise related to competitive products as well as process technologies not currently employed at BD
• Acquires and adapts new techniques and technologies
• ISO 13485, 21 CFR 820, and MDSAP regulatory and quality system knowledge