Associate Director Plant Quality

Becton Dickinson Medical Devices•Sandy, UT

19d•Onsite

About The Position

Reporting to the VP Quality Management, the Associate Director Plant QA provides direct management to technical and managerial staff at the Sandy location. The role significantly influences the definition of the global strategy and determines the tactics required to achieve objectives. Through outstanding communication; effective problem solving and active management of ambiguous situations; Associate Director ensures product safety, product quality and compliance with all relevant global regulations and customer expectations. Success is measured in terms of the frequency and scale of product quality and organizational issues as well as business process effectiveness. Through internal and external stakeholder engagement; and people development; the Associate Director Plant QA produces durable and industry leading results supporting key business drivers. Job Description 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.

Requirements

BS degree in Engineering or Life Sciences
5 years Managerial experience in Medical Device Plant

Nice To Haves

Master Degree in Business or Engineering
ASQ Certification
Six Sigma Certification
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

Responsibilities

As the Management Representative for the Sandy Plant, (as defined per ISO 13485:2003 and 21 CFR 820).
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 Sandy 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