Job Description Summary

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. 

Job Summary:

The Staff Quality Engineer is accountable as Quality Assurance representative to support reagent new product development and/or product and process sustaining activities through the application of Quality engineering skills for medical devices. Products include, but are not limited to IVD liquid and dried antibody.

For New Product Development activities, this person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.  This role will support the clinical IVD design and development.

For Sustaining Product activities, this person will understand, improve, and control operational processes in order to realize predictable product flow while satisfying established regulatory and BD standards of quality.  Activities include working independently or with a team to perform process validation, risk assessment and management, design control, CAPA, and supplier management.  Successful performance requires close work with quality management, operations, R&D, suppliers and/or BD associates to assure compliance with all BD quality policies, procedures, and practices.

Job Responsibilities:

• Supports quality activities for the development, implementation, and ongoing support of IVD reagent products and their related processes, equipment, and software.

• Is a Core Team member, or extended team member representing Site Quality on new product development projects and a team member for sustaining engineering projects.

• Acts as project lead for process improvement projects such as Shingi or Kaizen or projects as defined during annual Quality Objectives development.

• Guides the successful completion of major programs and may function in a project leadership role.

• Act as QA lead for facility design, validation controlled non-classified (CNC) manufacturing area Mentor, coach, and guide junior QE team members to enable development of self and others.

• Ensures quality conduct of projects, including design, data summary and interpretation, report preparation and review adherence to applicable regulations.

• Implements and communicates the strategic and technical direction for the product/project team Identifies any issues that may delay product or project and recommends appropriate action to be taken. 

• Independently determine options to address issues ensuring quality, and business continuity.

• Provides critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling, and control plans.

• Demonstrates working knowledge of applicable regulatory, corporate and/or Unit requirements.

• Provides audit support (preparation, closure, etc. activities). 

• Acts as site’s validation expert or subject matter expert for validation and be able to communicate with external and internal auditors.

• Revises policies/procedures. 

• Prepares reports, including quantitative / qualitative analysis, summaries, and protocols.

• Establishes a strong working relationship with all levels of operations in order to appropriately monitor and analyze in-process inspection, process control activity, and waste and reject rates, PM compliance, environmental control and customer complaint levels in order to take a lead role in identifying and documenting continuous improvement projects.

• Additional responsibilities maybe evaluated and or added, based on business and quality needs. 

• Performs other tasks assigned by management as required.