Staff Sterility Assurance Specialist
Elkton, MD, US
Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.
We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.
At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.
Join us and help shape wherever we go next!
Advancing healthcare with heart
Job Summary
The Staff Sterility Assurance Specialist is a technical leader on the Sterility Assurance team, responsible for independently leading critical sterility assurance projects and initiatives. This role solves complex problems, including cross-site troubleshooting, and serves as a mentor and subject matter expert (SME) for the Sterility Assurance function (industrial microbiology and sterilization – ethylene oxide, gamma radiation, and moist heat).
The Staff Specialist partners closely with Operations, Quality, Laboratory Operations, Engineering/PMO, and Regulatory Affairs, as well as external and internal sterilization partners, to ensure compliant, efficient, and robust sterilization processes and strategies that enable business operational directives. This role provides technical leadership on key business initiatives, and strengthens Sterility Assurance organizational capability through mentorship and cross-functional influence.
Job Details/Responsibilities
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Develop, author, and review technical protocols and reports related to microbiological testing, environmental monitoring, and sterilization validations, including product/process adoptions and change control. |
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Analyze and interpret complex data sets from microbiology and/or sterilization studies to support trend analysis, annual reviews, program optimization activities, and technical projects. Provide recommendations and strategies for continuous improvement. |
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Collaborate with cross-functional teams including Quality, Regulatory, Engineering/PMO, and Operations to ensure alignment on technical direction, strategy, and project timelines, as applicable. Provides technical leadership to new product development and design change/change control projects. |
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Support internal and external audits by preparing documentation, responding to observations, and participating in audit readiness activities. Represent Sterility Assurance in audit activities as needed. |
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Apply quality engineering principles to assess risk, drive continuous improvement, and ensure compliance with applicable technical standards (e.g., ISO 14644, ISO 11737, ISO 11135, ISO 11137, etc.). |
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Lead triage and resolution of complex technical issues spanning sterilization/microbiology process performance. Conduct and/or oversee root cause investigations and manage nonconformances and CAPAs related to the areas of microbiology and sterilization. |
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Serve as a technical leader of the Sterility Assurance team. Mentor and coach Sterility Assurance team members. Uplift technical capability and documentation quality. |
Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.
Knowledge, Skills and Abilities (KSA)
- High degree of scientific and analytical rigor, critical thinking
- Strong independent decision-making aligned with regulatory and technical requirements
- Attention to detail and documentation accuracy
- Cross-functional collaboration
- Effective communication (written and verbal)
Qualifications/ Background Experiences
- Bachelor’s degree in Microbiology, Molecular Biology, Biomedical Engineering, or related scientific field.
- Requires 9 – 12 years of experience in sterility assurance, with focus on ethylene oxide and gamma sterilization and industrial microbiology. Candidates with prior supervisory, team-lead, or mentoring responsibilities within these technical areas may qualify with experience at the lower end of the range.
- Strong technical writing skills with demonstrated experience in authoring scientific protocols, reports, investigations, risk assessments, etc.
- Expertise in standards and regulations governing EO and gamma sterilization modalities (e.g., ISO 11135, ISO 11137 series, ISO 11138 series, etc.) and microbiological principles (e.g., ISO 11737 series, ANSI ST72, ISO 14644 series, etc.).
- Experience supporting audits and working within a regulated environment (FDA, ISO, etc.).
- Proficiency in data analysis tools (e.g., Excel, Minitab) and statistical interpretation.
Preferred:
- Supervisory and/or leadership experience strongly preferred
- Experience with moist heat sterilization (ISO 17665) and/or vaporized hydrogen peroxide (ISO 22441)
- Experience with quality engineering tools (e.g., FMEA, CAPA, root cause analysis).
Familiarity with regulatory submission processes (e.g., 510(k), PMA).
It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.
Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.