BD · 1 day ago
Quality Engineer, Sterilization
USA UT - Salt Lake City BAS
Full-time
Onsite
Entry, Mid Level
2+ years expBD is one of the largest global medical technology companies in the world, and they are seeking a Quality Engineer, Sterilization to ensure the sterility assurance of medical devices throughout their lifecycle. The role involves developing sterilization validation protocols, overseeing sterilization cycle qualifications, and collaborating with various teams to integrate sterilization requirements into the design and development process.
Health CareMedical DeviceTechnical Support
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
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
Preferred
ASQ certifications (e.g., CQE, CQA) are a plus
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Richard Byrd
Executive Vice President and President of the BD Interventional Segment
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