Quality Engineer - Sterilization

Job Description

Summary:

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 /AST, 250 Media and DCM plants. This position will have supervisory responsibility over a group of Quality Engineers that support sterilization and validation.

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 Med Tech 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.

The Staff QE, Sterilization, Validation Site Lead 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 Validation.

• Sterility Assurance Champion: Lead our comprehensive site sterility assurance program across multiple sterilization modalities (ethylene oxide, radiation, moist heat, dry heat, and aseptic processing). Interpret ISO standards and translate corporate policies into actionable local procedures.
• Strategic Prioritization: Drive key site sterilization initiatives, validation projects, and supplier management objectives with a focus on continuous improvement and innovation.
• Quality Leadership: Provide expert recommendations to align site sterilization and microbiology capabilities with segment strategy, ensuring our validation team is properly resourced to meet regulatory requirements.
• Validation Excellence: Develop and maintain the site-level Validation Master Plan, establishing the foundation for all validation activities.
• Cross-Functional Collaboration: Build influential relationships with leadership team members to identify quality improvement opportunities and implement new processes that optimize efficiency.
• Problem-Solving Catalyst: Foster an environment of critical thinking, innovation, and rapid issue resolution to address complex sterility challenges.
• Project Leadership: Spearhead special projects aligned with team goals to meet microbiological, sterilization, and supplier management strategic priorities.
• Supplier Management: Guide strategic sourcing/procurement teams in qualifying and managing contract sterilization and testing suppliers.
• Technical Expertise: Serve as the site’s sterilization subject matter expert for process development, manufacturing environment design, test failure investigations, and audit responses.
• Metrics & Monitoring: Establish robust systems to track, report, and monitor sterility assurance and validation metrics, providing proactive recommendations for addressing negative trends.
• Quality Advocacy: Manage customer-impacting issues with a commitment to upholding the highest quality and compliance standards.
• Regulatory Knowledge: Apply working knowledge of FDA medical device regulations and international quality standards (21 CFR Part 820, ISO 13485, MDSAP, EU MDR/IVDR).
• Best Practice Sharing: Act as segment liaison among plants, businesses, and functions to communicate metrics, best practices, and successful technology advances.
• Inspirational Leadership: Lead by example as a recognized subject matter expert in validation and sterility assurance.
• Team Development: Mentor and develop personnel with dedicated succession planning and contingency management.
• Knowledge Transfer:
  Train site/business unit members on sterility assurance principles and practices.
• Industry Engagement:
  Participate in external technical associations (ISO, ASTM) related to sterilization, microbiology, and contamination control.
• Audit…