Job Description Summary

The Staff Quality System Specialist is accountable for the support of the continued development, improvement, implementation of the Quality Management System as well as maintaining compliance to regulations, standards, and corporate requirements. This position is also responsible to define and implement the supplier management activities required to approve site and local suppliers and maintain their approved status through their service lifecycle. This is achieved by providing collaborative support to quality leadership and working with other functions in the organization including Quality Engineering, Research and Development, Regulatory Affairs, and addition to corporate functions, regulatory agencies, and suppliers.

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. 

Responsibilities:

• Develop applicable Site / Unit procedures / work instructions and may make updates to Unit level procedures and policies.

• Serve as Supplier Quality leader for local and/or site-related suppliers (products and services) for multiple sites

  • Support identification suppliers and collaborate with cross-functional team to complete supplier selection process

  • Define and implement optimum supplier approval strategy. Facilitate, manage, and track supplier qualification and approval progress

  • Support Supplier creation/updates in Aravo

  • Manage and maintain Quality Agreements with suppliers, when needed

  • Provide on-going Supplier Quality Assurance support to all existing local and site-related suppliers

  • Collect and archive all relevant Supplier-related documentation

  • Support Supplier Quality performance monitoring.

  • Conduct supplier quality audits / assessments, as needed.

  • Manage changes initiated by suppliers. Coordinate with appropriate cross-functional teams

  • Support QA/QC lab with supplier activities related to product batch release and customer complaints as necessary

• Lead or support problem-solving and root cause analysis activities, as needed. Coach cross-functional teams as a problem-solving subject matter expert.

• Support internal / external / customer audits, including but not limited to hosting, auditing, subject matter expertise, and pre- and post-inspection activities, as needed

• Support activities related to management of Quality Systems processes, content, and electronic tools utilization, as needed

• Track trends of various quality data sources. Analyze and report on metrics.

• Assist with Quality Management Review content and related activities

• Support Site and WW Quality System continuous improvement initiatives

Education and Experience:

• BS degree in in Engineering, Science, or other related discipline

• At least 8 years of medical device, biologic, pharmaceutical, or diagnostic industry experience.

Knowledge and Skills:

• Strong knowledge of US and International regulations and standards that apply to the medical device industry including 21CFR820, ISO 13485, EU MDD/MDR, MDSAP country requirements as well as other requirements applicable to the product

• Auditing experience highly desirable

• Proficient communication, organizational and interpersonal skills.

• Ability to perform multiple tasks simultaneously and prioritize workload with minimum supervision

• Effective technical writing and analytical, technical, and problem-solving skills.

• Collaborative ability to work with diverse cross-functional teams

Work Environment:

• BD is a smoke-free campus.  Smoking and the use of electronic smoking devices, marijuana, or tobacco products are not allowed on BD property, grounds or in the parking areas.  We appreciate your cooperation in adhering to this policy

• False eyelashes, press-on fingernails, and Jewelry is not allowed on