Apply on Employer Site

BD (Tissuemed Ltd) · 1 week ago

Quality Engineer, Sterilization

Salt Lake City, UT

Full-time

Onsite

Entry, Mid Level

2+ years exp

BD is one of the largest global medical technology companies in the world. 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.

Health CareHospitalMedicalMedical Device

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

Qualification

Sterilization validationSterilization modalitiesQuality Engineering experienceGlobal sterilization standardsRisk management principlesAnalytical skillsASQ certificationsProblem-solving skillsCommunication skillsTeamwork

Required

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