Director Quality, Product Development

Director, Quality New Product Development

The Director, Quality New Product Development leads design assurance activities across Instruments, Software, and Reagents within the Global Product Development System (GPDS). This role is accountable for developing and implementing robust design control and quality assurance processes to support the development of Class I, II, and III medical devices including instruments, software, and reagents.

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 Med Tech 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.

• Develop and implement the quality strategy for instrument and reagent design, setting clear goals for the quality organization.
• Oversee quality engineering activities that support new product development, ensuring effective execution.
• Lead, mentor, and engage the quality design assurance team to foster growth and performance.
• Drive continuous improvement of quality processes and systems to enhance product quality, reduce costs, and increase customer satisfaction leveraging DFSS, DFM, Risk Management, and Reliability Engineering best practices.
• Manage design transfer activities across DS manufacturing sites.
• Ensure compliant and efficient quality operations related to engineering change management and other aspects of the quality system tied to New Product Development.
• Champion the use of quality tools including Six Sigma, risk management, root cause analysis, and Design of Experiments (DOE)

• Proven expertise in global medical device regulations and quality sciences, with a strong emphasis on Class III design; knowledge of In-Vitro Diagnostics is highly preferred.
• Exceptional leadership, communication, organizational, and project management skills.
• Deep understanding of design controls and risk management principles.
• Familiarity with software quality and reliability engineering is desirable.
• Experience interfacing with regulatory bodies such as FDA, ISO, PAL, Anvisa, and others.
• Minimum of 10 years in quality assurance or related fields, including at least 5 years in a leadership role within the Medical Device or Diagnostics industry.
• Bachelor's degree in Engineering, Science (e.g., Chemistry, Physics), or a related technical field;
  Master's degree in Engineering, Science, or Business Administration is preferred.
• Professional certifications (e.g., CQA, CQE, SQE, CQM) are advantageous.

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.

Primary Work Location : USA MD - Sparks - 7 Loveton Circle