Quality Engineer - Sterilization

Overview

Job Description

Summary:

This position ensures product safety, product quality, and compliance with all relevant global regulations and customer expectations. It drives the implementation and sustainability of the sterility assurance programs for the /AST, 250 Media and DCM plants, with 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. This role contributes to the strategy and tactics required to achieve site and business objectives for both Sterilization and Validation. It requires leadership and engagement across teams to support sterilization and validation initiatives.

• Sterility Assurance Champion:
  Lead the 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 the validation team is 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 critical thinking, innovation, and rapid issue resolution to address complex sterility challenges.
• Project Leadership:
  Lead special projects aligned with team goals to meet microbiological, sterilization, and supplier management 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, 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 high quality and compliance standards.
• Regulatory Knowledge:
  Apply working knowledge of FDA medical device regulations and international 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 and best practices.
• Inspirational Leadership:
  Lead by example as a recognized SME in validation and sterility assurance.
• Team Development:
  Mentor and develop personnel with 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 Support:
  Provide guidance during sterility assurance and technical audits.
• Team Leadership:
  Lead and inspire a team of sterility assurance and validation quality engineers.

Required Qualifications

• Bachelor's degree in Engineering, Microbiology, Biology, Medical, Technology or life science.
• 6 years of experience in sterilization, microbiological and/or supplier management in medical device and/or healthcare industry.
• Demonstrated experience in handling and gaining consensus across cross-functional teams within sites.

Preferred Qualifications

• Industry-recognized certification in a Quality System Element specialty (e.g., ASQ Certified Quality Auditor, Quality Manager, Quality Engineer).
• Experience or training with Six Sigma methodology and project management techniques.
• Related Standards Management experience (ISO, ASTM).
• Auditing experience and certification as a technical auditor.

• Ability to liaise with regulatory agencies as required.
• Knowledge of cGMPs, pharmacopeias (USP, EP), standards (ISO, EN) and regulations (FDA, NMPA, EU) with regard to laboratory practices, process environments, sterilization methods, ethylene oxide residuals, and bacterial endotoxin.
• Familiarity with ISO sterilization/sterility assurance standards for radiation (ISO 11137), moist heat (ISO 17665), ethylene oxide (ISO 11135), dry heat (ISO 20857), clean rooms (ISO 14644) and aseptic processing (ISO 13408).
• Effective communication and technical writing skills.
• Ability to work effectively with all levels of BD associates to accomplish business…