Senior Quality Engineer

Job Description Summary

The Sr. Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.

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.

• Consistent application of technical principles, theories, concepts, techniques, and quality sciences/tools.
• Proven problem‑solving skills.
• Makes measurable improvements to BD processes and procedures. Ensures that all design control and production/process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.
• Acts as a team member representing Quality on new product development and sustaining engineering projects.
• Reviews and has Quality Engineering approval authority for new and modified design/process specifications including product performance specification, test methods, etc.
• Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and good manufacturing practices (Auditor‑in‑training).
• May perform other duties as required.

• Typically requires a minimum of a bachelor’s degree in science, engineering, or other relevant discipline and a minimum of 5 years relevant experience or a combination of equivalent education and relevant experience.

• Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products.
• Applied knowledge of Corporate and/or Unit requirement.
• Able to contribute to the completion of specific programs and projects.
• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.
• Able to revise policies and procedures.
• Able to make presentations.
• Can independently determine and develop approach to solutions.
• Able to provide guidance and work direction to lower level project developers.
• Can design and perform development working independently within defined parameters with minimal supervision required.
• Experience with BD software systems utilized in the Quality Systems is desirable.
• Must have knowledge/specialization in one or more of the following areas:
• Acceptance sampling theory and application
• Statistical process control methods and application
• Measurement system/test method knowledge and analysis
• Quality planning
• Failure analysis investigation
• Design of Experiments
• Process mapping and value stream analysis
• Hypothesis testing
• Descriptive statistics
• Process capability analysis
• Basic quality tools:
  Pareto, box plots, histograms, scatter diagrams, etc.
• Risk Management
• Supplier quality management
• Auditing
• Design/development tools
• Process validation
• Software validation

At BD, we prioritize on‑site collaboration because we believe it fosters creativity, innovation, and effective problem‑solving, which are essential in the fast‑paced healthcare industry. For most roles, we require a minimum of 4 days of in‑office presence per week to maintain our culture of excellence and…