Quality Engineer, Sterilization

BD•Salt Lake City, UT

2d•Onsite

About The Position

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. 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. 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.

Requirements

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 11137) 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.

Nice To Haves

ASQ certifications (e.g., CQE, CQA) are a plus.

Responsibilities

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.