Director, Quality Systems (SM)

BD; Wyckoff (NJ); On-site; USD 212,000 - 339,000; Full time

Job summary

BD is seeking a seasoned QA leader to drive the Specimen Management Quality Systems (SM QMS) and ensure alignment with MDR/IVDR and other global regulations. You will lead development, implementation, and continuous improvement of QMS processes, acting as the primary liaison for audits and regulators while coaching future quality leaders across a global network.

The role focuses on building a robust, compliant, and efficient QMS that supports BD’s mission to advance health, with frequent

Qualifications

• Minimum 10 years of QA leadership experience in a regulated environment.
• Expert knowledge of FDA QSR, ISO 13485, EU MDR/IVDR requirements.
• Experience implementing and maintaining QMS across multiple sites.

Responsibilities

• Lead Specimen Management Quality Systems (SM QMS) strategy across locations.
• Design, develop and implement QMS processes aligned with corporate goals.
• Serve as point person for internal and external audits and regulatory inspections.
• Coordinate SM communications with regulators to build consistency and trust.
• Develop long-term SM QMS strategy and build future quality leaders.

Skills

Quality leadership

Regulatory knowledge

Audits

QMS development

Cross-functional leadership

CAPA

Document control

Education

BS degree in technical field

Job description

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 MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job 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.

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

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.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. 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 orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$211,900.00 - $339,000.00 USD Annual