Job Description Summary

Sterilization, Validation & Supplier Management

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 QE, Sterilization, Validation and Supplier Management is responsible for contribution to the definition of the strategy and tactics required to achieve site/business unit/business line objectives for both Sterilization and Supplier Management. 

This position ensures product safety, product quality, and compliance with all relevant global regulations and customer expectations. Additionally, it drives the implementation and sustainability of the sterility assurance (sterilization and contamination control) programs for the ID/AST, 250 Media and DCM plants. This position will have supervisory responsibility over a group of Quality Engineers that support sterilization, validation and supplier management.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

Strategy Awareness, Development and Implementation

• Maintaining compliance to, the site sterility assurance program for all sterilization modalities, including ethylene oxide, radiation, moist heat, dry heat and aseptic processing; for interpreting ISO standards, corporate sterility assurance and sterilization policies and procedures. Implementing local procedures and standard methodologies to comply to those policies;

• Prioritize key site sterilization, validation and IDS supplier management objectives and continuous improvement activities.

• Lead site level supplier management in the development of strategy implementation plans.

• Provide recommendations to ensure that site sterilization and microbiology capabilities are aligned with segment strategy. Assist the quality organization in ensuring the validation team is organized and resourced to fulfill its obligations and to comply with applicable regulations and procedures. This includes identifying BD sterilization and /or validation resource needs related to changes in manufacturing architecture, new products/processes, and the validation of additional sterilization equipment.

• Maintain site level Validation Master Plan

• Effectively network and communicate with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies.

• Enable problem solving, critical thinking, innovation and rapid issue corrections.

Technical Support

• Support special projects and programs as specified in team goals, and/or as required by manager to meet microbiological, sterilization and supplier management strategic priorities.

• Provide guidance, as needed, to strategic sourcing / procurement functions in the qualification and on-going management of contract sterilization and testing suppliers.

• Serve as the site sterilization SME specific to process development, manufacturing environment design, test failure investigations and audit responses related to sterility assurance as needed.

• Establish systems to track/report/monitor the sterility assurance, validation and supplier management metrics and provides proactive recommendations for negative trends, process improvement and risk mitigation.

• Manage customer impacting issues; prioritizing quality and compliance solutions that uphold the company and its standards.

Knowledge Management

• Working knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, MDSAP, EU MDR/IVDR)

• Act as segment liaison among plants, businesses, and functions in the communication of metrics, best practices, improvement programs and successful technology advances.

• Perceived as inspiring leader possessing subject matter expert knowledge of validation/sterility assurance.

• Mentor and develop personnel, including dedicated succession planning and contingency management.

• Train site/business unit members as needed.