Associate Quality Director

bdx; Sumter (SC); On-site; USD 180,000 - 240,000; Full time

Job summary

BD seeks an Associate Director, Plant QA to lead the Sumter facility's quality strategy and operations, reporting to the VP of Quality Management. You will supervise technical and managerial staff, ensure product safety and regulatory compliance, and drive continuous improvement across quality systems.

You will collaborate with stakeholders, manage CAPA, internal and supplier audits, change control, and release of components and finished products, including on-site sterilization oversight.

Qualifications

• BS degree in Engineering or Life Sciences.
• 5 years managerial experience in highly regulated Medical Device Plant.
• Master degree and certifications preferred.

Responsibilities

• Quality System Champion—establish, implement, and maintain quality processes.
• Executive Quality Liaison—deliver performance reports to top management.
• Regulatory Awareness Ambassador—foster regulatory and customer requirements.
• Inspection Point Person—primary contact for FDA, ISO, audits.
• Compliance Program Overseer—manage CAPA, NMFs, audits, change control, calibration, investigations.
• Product Release Guardian—oversee lab operations and release decisions.
• Strategic Leadership Team Member—contribute to Plant Leadership Team.
• Quality Strategy Architect—develop and maintain quality plans.
• Continuous Improvement Driver—lead QA projects for compliance and improvement.
• Talent Developer—build high-performing QA team.
• Financial Steward—manage QA department budget.
• Problem-Solving Partner—drive investigations with cross-functional teams.
• Product Development Collaborator—support new product initiatives and design transfer.
• Safety Compliance Advocate—adhere to BD safety regulations.

Skills

Leadership

Regulatory Knowledge

Quality Management

Strategic Thinking

Problem Solving

Education

BS degree in Engineering or Life Sciences

Master Degree in Business or Engineering

ASQ Certification

Six Sigma Certification

Job description

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

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:

• 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 visit https://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

Work Shift