Associate Director, Quality Systems

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics.

Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters' passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

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 Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Role Overview

* Serve as a key quality leader responsible for designing, deploying, and sustaining a robust, compliant, and scalable Quality Management System (QMS) across the World‑Wide Advanced Diagnostics (ADx) division.

* Drive standardized and unified quality processes globally, ensuring compliance with FDA QSR, ISO 13485, MDSAP, MDR/IVDR, Japanese PAL, and other applicable global standards.

* Act as a strategic partner to senior leadership, ensuring quality systems support patient safety, regulatory compliance, and operational excellence across clinical and industrial IVD and medical device applications.

* Operate with a high level of autonomy, exercising independent judgment to solve complex quality system challenges while aligning resources, budgets, and schedules with ADx strategic goals.

* Report directly to the Sr. Director, Quality Systems, supporting the ongoing development, implementation, and continuous improvement of the global QMS.

Key Leadership & Accountability Areas

* Function as the Management Representative for the ADx Quality Management System.

* Provide end‑to‑end ownership of:
Management Review processes, Audit readiness and inspection management, CAPA effectiveness, Document Control, Training, and Change Control

* Lead, coach, and develop the ADx Quality Systems team, fostering a culture of quality, accountability, and continuous improvement.

* Maintain oversight of global quality metrics and Key Design Goal (KDG) metrics across Advanced Diagnostic Systems.

Quality Systems & Compliance Responsibilities

* Develop, implement, and govern quality information and reporting systems to support regulatory compliance and data‑driven decision‑making.

* Develops and implements quality information reporting systems and administers FDA, ISO 13485, MDSAP, MDR / IVDR and Japanese PAL standards including audits, certification and the Management Review process.

* Ensure consistent and effective deployment of quality system processes globally, including for custom products.

* Stay current on evolving U.S. and international regulations, proactively initiating procedural changes to ensure continued compliance.

Audits, Inspections & Continuous Improvement

* Lead and host external regulatory inspections and audits, ensuring strong pre‑inspection readiness and effective post‑inspection remediation.

* Prepare and manage responses to audit nonconformities, partnering with senior management for review and approval.

* Ensure global quality system audits are planned, executed, and followed up effectively.

* Champion continuous quality improvement through:
Strategic use of the CAPA system, Direct involvement in situation analysis,…