Job Description Summary

The Quality Specialist I is accountable for distribution quality systems, nonconforming and hold product disposition, and ensuring compliance with procedures and external regulatory requirements.

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:

• Responsible for monitoring assigned quality system performance through established metrics and/or quality objectives.

• Collaborate with functional process owners to train, mentor and/or facilitate QMS requirements

• Continuous process improvement.

• Maintain awareness of and follows applicable corporate quality procedures.

• Maintain awareness of and follows applicable external regulatory requirements.

• Responsible for quality systems as a Subject Matter Expert (SME), ensuring application and compliance to the following Quality Systems in a manner that meets the scope of storage and distribution processes.

  • Holds and product disposition and movement within the WMS/SAP

  • Zero Escape

  • Intracompany Claims

  • QMS Audits

  • Metric Data Analysis

  • Operations Support

  • Designated Representative License

  • SME for ISO 13485, 21 CFR 820, and Corporate Policies / Procedures when appropriate.

  • Customer service claims.

• Responsible for ensuring site is meeting the terms and obligations of local wholesale drug licenses as the designated representative.

• Be aware of the other positions' responsibilities to assist in times of urgency, breaks, absences, or vacation.

Education and Experience:

• Bachelor’s degree science preferred; or,

  • Associates degree, or a combination of equivalent education and experience, required in lieu of a Bachelor’s degree.

• 3 years experience in a regulated environment and proficiency with SAP, WMS, and other ERP platforms, preferred.

• Industry Recognized certification in a Quality System Element or specialty (e.g., ASQ Certified Quality Auditor, etc.), preferred.

Knowledge and Skills:

• Self-motivated and directed, requiring minimal supervision.

• Demonstrated ability to work in teams to obtain results.

• Effective skills in analytical thinking and problem solving.

• Highly proficient in the use of a PC, with strong knowledge of Microsoft Office Suite.

• Expert with SAP, WMS, and other ERP platforms.

• Excellent technical writing skills.

Physical Demands:

• The physical demands described are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, in accordance with the Americans with Disabilities Act of 1990 and applicable state and local laws.  While performing this job, the associate is regularly exposed to episodes of walking, standing, stooping, kneeling, balancing, crouching, reaching, pushing/pulling, grasping, hearing, twisting, lifting, frequent use of hand to finger, handle, feel, pick or type which can include repetitive motion of the wrists, hands or fingers.  The associate may occasionally be required to climb. The job may require lifting over 50lbs in some areas but not all.  Associate must have normal field of vision corrected to 20/40 in each eye and must have hearing sufficient to safely operate MHE [Material Handling Equipment] in a manufacturing/distribution environment.

Work Environment:

This position typically works in a normal office environment with a warehouse / supply chain environment. The noise level in the work area is quiet to moderate.  At times, position may be required to support operational activities in the distribution center. 

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