Associate Director Plant Quality

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.

Responsibilities :

As the Management Representative for the Sandy 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 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 oversightResponsible 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 :

Preferred Qualifications :

Knowledge and Skills :

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.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and / or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

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.