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 compli