Senior Principal Quality Engineer

Job Description Summary

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and BD systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

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 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.

• Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.

• Own and close complaint Engineering investigations for BD electronic complaints.

• Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. find opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.

• Develop, update, and maintain technical content of risk management files for NPD and existing products.

• Develop training and documentation materials for production (e.g., work instructions) to enable seamless knowledge transfer of project and manufacturing processes.

• Support product upgrading and reworking tasks as needed as Quality Engineer.

• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.

• Train, coach, and guide lower-level employees on routine procedures

• Other incidental duties assigned by Leadership

• Bachelor's Degree in Engineering or Scientific field

• Minimum of 8 years experience, including strong electromechanical medical device experience

• CAPA and complaints management experience required

• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills

• Strict attention to detail

• ASQ Certified Quality Engineer (CQE)

• Considers the cause and effect of activities

• Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment.

• Determines or effectively recommends course of action after considering potential risks of alternatives by comparing and evaluating possible courses of action after considering various possibilities

• Works independently without close supervision

• Applies their knowledge in following procedures or in determining procedures to follow or determining whether specified standards are met

• Proven expertise in usage of MS Office Suite

• Ability to read and interpret drawings

• Proven expertise in statistical techniques

• Ability to translate complex and technical information to all levels of the organizations

• Recognized as an expert in own area within the organization

• Expert knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)

• Expertise of Six Sigma concepts with the ability to lead projects applying these principles

• Expertise in applying Quality Engineering concepts (e.g., CQE body of knowledge) with the ability to lead projects using these principles

• Advanced problem-solving, organizational, analytical and critical thinking skills

• Expert understanding of processes and equipment used in assigned work

• Strong leadership…