Job Description Summary

This position manages and coordinates compliance of the Global Engineering and Product Development quality engineering functions. This position is responsible for providing strategic direction and support regarding Global Engineering and Product Development with respect to current or emerging quality, regulatory and compliance issues. Responsibilities include assisting in the development of tools or guidance documents to promote consistent implementation of product development process and quality/compliance strategies.

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. 

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Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• Provide mentoring, leadership and guidance to the quality engineering staff and technicians whose function is to develop and optimize design control process, develop and validate new equipment and test methods, assess current or emerging quality and regulatory compliance gaps, control and resolve nonconforming issues and lead continuous efforts.

• Perform aspects of management in the administration of the QA department which include goal setting, planning, organizing, direction, and evaluating direct reports.

• Lead Quality Engineering support for design and changes including incorporation of new products into the product portfolio; responsible for Quality oversight for verification and validation activities.

• Support submissions and renewals on International, CE, TGI, Japan, China, clinical studies, for PIVC products.

• Provide leadership and expertise on a diverse scope of quality/compliance issues where analysis of data is required to draw conclusions, identify risks, and propose possible solutions.

• Oversee International complaints and drive investigations and mitigation efforts along with developing complaint reduction goals for Int’l geographies.

• Understand variances in clinical processes in Int’l geographies and obtain appropriate design inputs.

• Apply appropriate Quality and Compliance principles, tools and techniques to develop and optimize systems that are aligned with the overall company strategy, Global Product Development, Quality Policy and Regulatory requirements affecting international market growth and continuous compliance improvements.

• Establish key performance indicators for the Quality Engineering and ensure support of global business objectives.

• Participate in training and provide input to training of other employees on division and corporate procedures and policies, technical and managerial skills.

• Work with International teams to help with the development of annual international product lines and interpret regulatory requirements in the light of current guidance and international regulatory body field activity.

• Work with cross functional U.S. and International teams to develop, adapt, and execute strategic quality plans for new product development, global product registration, manufacturing, supplier management and product/business acquisitions throughout multiple markets taking into specific cultural and regional considerations.

• Interact with local regulatory agency and oversee test labs to ensure a smooth working relationship, and compliance to BD, FDA and international regulatory requirements during New Product Development, design transfer and global product registration.

• Keep abreast of new methods and developments in the Regulatory and Quality fields and shares attained knowledge with cross-functional team members.

• Ensure international vendor audits are performed per schedule and any deficiencies are resolved in a timely manner.

• Develop plans and strategies to assure BD is successful in all compliance audits.

• Provide effective leadership, communication and training that will strengthen and continually improve company-wide level of internal and external quality.

Education and Experience:

• B.S. degree in Mechanical or Biomedical Engineering or similar