Becton Dickinson

Becton Dickinson

Associate Director, Quality Systems

USA MD - Sparks - 7 Loveton Circle, USA · Director

Sponsorship not specified$154k-$255kDetected 106 days ago
CompliancePerformance ManagementFDA RegulatoryMedical DevicesLeadershipCollaborationProblem SolvingMentoring

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odds of building a lasting career here

56Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role70
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

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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.
  • 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.
  • Prepare and manage responses to audit nonconformities, partnering with senior management for review and approval.
  • Design and implement a compliant, efficient change control process, including digital and e‑QMS solutions.
  • Develop, manage, and monitor budgets for: Capital expenditures, Operating supplies, Labor and staffing
  • Drive associate engagement, training, and professional growth within the Quality Systems organization.
  • 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.

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
  • 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.
  • 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.

Benefits

  • 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.
  • 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.

Company info

  • We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world.

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
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This listing is sourced directly from Becton Dickinson's careers page and normalized into a canonical job model.