Job Description Summary

Support the Quality function in a particular manufacturing area by developing and maintaining quality control plans, dealing with non-conforming material, customer complaints, CAPAs, and providing quality metrics to Manufacturing and Quality management. Assure the manufacturing areas are compliant to required regulations and support continuous improvement activities.

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 Responsibilities:

1.      Support the implementation of new processes and changes by developing quality plans, approval of validation plans and protocols, inspection methods, work instructions, and raw material specifications and inspection plans.

2.      Analyze and interpret inspection data, process data, and other quality metrics to prevent quality problems and to identify continuous improvement opportunities.

3.      Responsible for the disposition, documentation, root cause, and corrective action activities of non-conforming material.

4.      Support manufacturing and quality process improvement projects as an effective team member or leader using Continuous Improvement and Six Sigma tools.

5.      Develop working knowledge of applicable regulatory, Corporate and/or Unit requirements.

6.      Facilitate Change Control.

7.      Provide audit support for customer and regulatory audits (preparation, closure, etc.)

8.      Communicates across functions / departments for assigned areas of responsibility.

9.      Follow all local, state, federal, and BD Safety regulations, policies, and procedures including RCRA Hazardous waste regulations.

10.   Follow all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.

11.   Other duties as assigned.

 

*This is not intended to be an all-inclusive listing of duties.  Other job-related duties may be required.

Education and Experience:

This position requires:

1. Requires a minimum of a Bachelor’s Degree or 4 years combined relevant education and related experience.

Preferred qualifications:

1. Bachelor's Degree in STEM

2. Basic knowledge of applicable regulatory requirements.

3. Training in statistics.

4. Medical device experience.

Knowledge and Skills:

1.     Basic understanding of the role of quality in an organization.

2.     Good Documentation Practices

3.     Basic Computer skills

4.     Effective written and oral communication skills

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:

1. This position is in a clean room or laboratory manufacturing environment and the physical demands described are representative of those that mu