Director Quality, New Product Development

BD (Becton, Dickinson and Company) • Sparks, MD

56d • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• Professional certifications (e.g., CQA, CQE, SQE, CQM) are advantageous.

Responsibilities

• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Industry: Miscellaneous Manufacturing
• Number of Employees: 5,001-10,000 employees