Quality Engineer, Sterilization

Quality Engineer, Sterilization

The Quality Engineer, Sterilization will be responsible for ensuring the sterility assurance of Bard Access Systems' medical devices throughout their lifecycle, from design to post‑market surveillance, in compliance with global regulations and standards.

• Develop, implement, and maintain sterilization validation protocols and reports for new and existing medical devices, applying various sterilization modalities (e.g., EtO, Radiation, Steam).
• Oversee and perform routine sterilization cycle qualifications, re‑qualifications, and dose audits to ensure ongoing compliance and product safety.
• Conduct sterilization‑related root cause analysis, investigations, and CAPA activities for non‑conformances, deviations, and complaints.
• Collaborate with R&D, Manufacturing, and Regulatory Affairs teams to integrate sterilization requirements into the design and development process.
• Support supplier quality activities related to sterilization services, including audits and performance monitoring.
• Participate in risk management activities, assessing and mitigating sterilization‑related risks throughout the product lifecycle.
• Review and approve sterilization‑related documentation, including specifications, procedures, and change control requests.
• Stay current with evolving international sterilization standards (e.g., ISO 11135, ISO 11137, ISO 14937, AAMI TIRs) and regulatory requirements (e.g., FDA, MDR).
• Provide technical expertise and training on sterilization principles and practices to internal teams.
• Support internal and external audits (e.g., FDA, Notified Body) related to sterilization processes and documentation.

• Bachelor's degree in Biomedical Engineering, Chemical Engineering, Microbiology, or a related scientific/engineering discipline.
• 2+ years of experience in a Quality Engineering role within the medical device industry, with a strong focus on sterilization.
• Demonstrated knowledge and experience with various sterilization modalities (e.g., EtO, Radiation, Steam) and associated validation processes.
• Familiarity with global sterilization standards (e.g., ISO 11135, ISO 11137, ISO 14937) and medical device regulations (e.g., FDA 21 CFR Part 820, EU MDR).
• Experience with risk management principles and tools (e.g., FMEA) as applied to sterilization.
• Strong problem‑solving, analytical, and critical thinking skills.
• Excellent written and verbal communication skills, with the ability to clearly articulate complex technical information.
• Ability to work effectively both independently and as part of a cross‑functional team.
• ASQ certifications (e.g., CQE, CQA) are a plus.

Primary

Work Location:

USA UT - Salt Lake City BAS

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.