Becton Dickinson
Associate Director, Quality Systems
USA MD - Sparks - 7 Loveton Circle, USA · Director
Sponsorship not specified$154k-$255kDetected 15 days ago
CompliancePerformance ManagementFDA RegulatoryMedical DevicesLeadershipCollaborationProblem SolvingMentoring
About the role
- 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.
- 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.
- Director, Quality Systems, supporting the ongoing development, implementation, and continuous improvement of the global QMS.
Responsibilities
- Drive standardized and unified quality processes globally, ensuring compliance with FDA QSR, ISO 13485, MDSAP, MDR/IVDR, Japanese PAL, and other applicable global standards.
- 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.
- 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.
- Lead and host external regulatory inspections and audits, ensuring strong pre‑inspection readiness and effective post‑inspection remediation.
- 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.
Requirements
- 8 years' experience in Quality, Regulatory, or Operations
- 5 years' experience as a people leader
- Thorough knowledge of quality systems regulations. (ISO
Nice to have
- Professional certification (i.e, CQA, CQE, SQE, CQM, Etc)
- 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.
- At BD, you'll discover a culture in which you can learn, grow and thrive.
- To learn more about BD visit https://bd.com/careers.
- Becton, Dickinson, and Company is an Equal Opportunity Employer.
- USA MD - Sparks - 7 Loveton Circle
- You can learn more on our career site under " Our Commitment to You."
Skills
- Thorough knowledge of quality systems regulations. (ISO; FDA; MDSAP)
- Effective financial management, planning, and organizational skills.
- Effective analytical, technical, and problem solving skills.
- Effective meeting and presentation skills.
- Effectively manage conflict.
- Ability to work in or direct teams to obtain results
- Ability to organize and supervise people and activities
Compensation
- $154,400.00 - $254,800.00 USD Annual
Benefits
- Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service.
- 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.
- 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.
Company info
- We are the people who give possibilities purpose
Visa & Work Authorization
- 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 orientatio
Apply directly at Becton Dickinson →Create a free account for alerts like thisView Becton Dickinson immigration profile
This listing is sourced directly from Becton Dickinson's careers page and normalized into a canonical job model.