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

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visithttps://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

Primary Work Location

USA SC - Sumter

Additional Locations

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Job Description

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.

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