Associate Director Plant Quality

Job Title

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.

Responsibilities

As the Management Representative for the Sandy Plant, 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 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
• Product Release Guardian - Supervising laboratory operations and release personnel to ensure only safe, effective products reach customers, including on-site sterilization quality oversight
• 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
• 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 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

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. 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 health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.