Becton, Dickinson and Company

Director, Quality Systems (SM)

Becton, Dickinson and Company • $211K — $339K *
Franklin Lakes, NJ 07417In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • BS degree in a technical field required; certifications such as CQE, CSQE, CQA, or CQM preferred
  • 10+ years of QA leadership experience in global organizations
  • Expert knowledge of FDA QSR, ISO-13485, EU MDD/IVD, and EU MDR/IVDR regulations
  • Willingness to travel internationally to engage with SM entities
  • Proven experience in developing long-term QMS strategies
  • Ability to manage and develop future quality leaders
  • Experience in leading cross-functional QMS improvements for medical devices

Responsibilities

  • Ensure compliance with global regulatory standards for medical and non-medical devices
  • Maintain an efficient and simplified SM Quality Management System (QMS)
  • Lead and influence quality networks to align with organizational goals
  • Streamline SM product development processes under the QMS
  • Ensure an effective QMS delivering high-performing, safe products

Benefits

  • Opportunity for leadership in a dynamic quality systems environment
  • Engagement with global teams and regulators
  • Exposure to cutting-edge regulatory practices
  • Impactful role influencing the future of product compliance
  • Professional growth and development in a key leadership position
Full Job Description
Job Description

This role will lead the Specimen Management Quality Systems team and drive these systems to meet changing regulatory demands (e.g., MDR, QMSR). Drive the design, development, and implementation of these QMS processes with corporate and business objectives. Act as the point person for internal and external audits and inspections, with organizational skills and strong communication to regulatory agencies.  Coordinate external SM communications with regulators to establish consistency and trust. Act as the point of contact for internal and external audit actions.

Responsibilities:

Drive SM Quality Systems strategy as follows: 

  • Compliance – Ensure compliance with global regulatory standards for medical devices and non-medical devices across various physical locations and entities. 
  • Effective and efficient Quality Management — Ensures the SM QMS is efficient, compliant and simplified to promote the best quality practices. 
  • Leadership – Leads or influences quality networks, businesses, associates and capital resources toward the effective promotion and alignment of organizational goals to the company’s mission and vision. Demonstrates strong big-picture thinking; effectively integrates and balances long-term opportunities and challenges, with day-to-day activities. Understands implications of decisions and communications both written and verbal. 
  • Innovation— The SM product development process is conducted under the SM QMS. This QMS must be streamlined to develop new products and change management practices to ensure we deliver a compliant world class customer experience. 
  • Growth - Responsible for the effectiveness of the SM QMS. An effective QMS delivers high performing, safe products that meet and exceed customer expectations. 

Qualifications:

  • The candidate should have at least a BS degree in a technical field. Knowledge of industry QMS software tools (e.g., Trackwise, SAP, and PEGA Systems) is desirable. Certifications within Quality disciplines (i.e. CQE, CSQE, CQA, CQM) strongly preferred 
  • A minimum of 10 years of experience as either a leader or senior leader of QA in a site/business unit having broad responsibility for QMS process, or as a leader responsible for a corporate wide QMS in a highly matrixed global organization. 
  • Expert knowledge of applicable regulations and standards including FDA QSR, ISO-13485, EU MDD/IVD, and EU MDR/IVDR
  • Must be willing to travel and engage SM entities worldwide to understand their needs and develop QMS processes that meet those needs. 
  • Experience developing a long-term strategy for the SM QMS and be able to fulfill this strategy. 
  • Experience managing staff, developing future quality leaders and building an organizational culture is required 
  • Ability to effectively operate in a matrix environment and influence and interact with senior enterprise leaders and functional leaders on a regular basis is required 
  • Demonstrated success leading cross-functional development, implementation, application, maintenance, and continuous improvement of Quality Systems for medical devices (including CAPA, Change Control, Document Control, Post Market Surveillance, Supplier Controls and Internal Audit, as applicable).
  • Demonstrated ability to develop a QMS that is both compliant and efficient 
  • Excellent verbal and written communication skills and have an ability to influence others in the organization. They must be able to develop a long-term strategy for the SM QMS and be able to fulfill this strategy 

Primary Work LocationUSA NJ - Franklin Lakes

Salary Range Information

$211,900.00 - $339,000.00 USD Annual

About Becton, Dickinson and Company

BD is a global technology company that provides diagnostics and technologies for frontliners. Through their solutions and services, they assist scientists in detecting diseases and advanced researchers' on developing diagnoses and therapeutics. BD was established in 1897 by Farleigh Dickinson and Maxwell Becton in East Rutherford, New Jersey.

Becton, Dickinson and Company Careers

Join the innovative world of Becton, Dickinson and Company (BD), a global medical technology company that is actively seeking driven, dedicated professionals to join our team. At BD, we are committed to advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. This commitment provides the foundation for a workplace where you can engage in meaningful work and where job opportunities abound.

Work You’ll Do

At BD, you will be part of a culture that values diversity, leadership, and innovation. Our team members are empowered to lead and inspire from day one. Join us and contribute to our mission of advancing the world of health through your professional skills and personal passion.

Transform Your Career

BD offers a unique position in the marketplace that combines industry expertise, leadership in medical innovation, and a collaborative culture to help you grow your career. Whether you are looking for an entry-level position or a more senior role, we provide the tools and support for your professional growth through comprehensive training and development programs.

Innovative Work Environment

Our team at BD is composed of more than 65,000 associates across the globe. These dedicated professionals work at the intersection of technology and healthcare, where they drive innovation and ensure that we stay ahead in a rapidly evolving industry. By joining BD, you will work alongside some of the brightest minds in the industry.

Internship and Employment Opportunities

Start your career with BD through our internship programs or dive straight into a full-time position. We offer a range of opportunities that allow you to explore different areas of our business and find a path that aligns with your career goals. Our hiring process is designed to be transparent and engaging, ensuring that all candidates—whether submitting a resume for an internship or a senior position—feel valued and informed.

Benefits and Culture

BD is proud to offer competitive benefits that support the health, well-being, and financial security of our employees and their families. From comprehensive health insurance to employee wellness programs and flexible working arrangements, we prioritize the well-being of our team members. Our inclusive culture encourages networking, continuous learning, and the sharing of ideas in a diverse and welcoming environment.

Join Our Team

Explore the job opportunities at BD and discover how your expertise can help shape the future of healthcare. Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players.

Stay Connected

Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. See what exciting and rewarding opportunities await at Becton, Dickinson and Company.

Explore Careers at BD

Whether you're preparing for your first interview or looking to advance into a leadership role, BD offers career paths that foster continuous growth and innovation. Join us in our mission to improve medical outcomes and enhance patient care worldwide.

SEARCH BD JOBS

READ CAREERS BLOG

JOB ALERT EMAILS

At Becton, Dickinson and Company, we are more than just a company; we are a community that is dedicated to making a difference in the lives of people all around the world.
Learn more about Becton, Dickinson and Company
Size
75,000 employees
Market Cap
$72 billion
Industry
Healthcare
Net Income
$1.6 billion
Founded
1897
5 Year Trend
+9.3%
Revenue
$18.2 billion
NASDAQ
BDX
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Becton, Dickinson and Company

More Pharmaceuticals & Biotech Jobs

Find similar Director, Quality Systems (SM) jobs:

NationwideFranklin Lakes, NJ