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Sterilization Subject Matter Expert (m/f/d)

Dresden, Deutschland

Bewerben
Job ID 58107 Funktionsbereich Forschung & Entwicklung Vollzeit/Teilzeit Vollzeit Einstiegslevel Berufserfahrene

Sterilization Subject Matter Expert (m/f/d)

[title]
Sterilization Subject Matter Expert (m/f/d)
Permanent

About Heraeus

Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead.


About Heraeus Medevio

Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds.

To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.

About the Role

As a Sterilization Subject Matter Expert at Medevio, you will play a key role in supporting global development projects and our clients across the full medical device lifecycle by planning and managing the sterilization activities for our products in collaboration with the external sterilization providers, including full sterilization validations and product adoptions. You will collaborate closely with internal cross-functional teams including Product Development, Operations, Quality, and Regulatory Affairs, but also external sterilization providers and our customers, ensuring sterilization strategies are aligned with project goals and regulatory requirements.

The following challenges await you:

  • Lead sterilization activities for Medevio projects and clients worldwide, covering the entire medical device lifecycle.
  • Develop effective sterilization strategies based on customer, product and regulatory requirements with a high focus on EO sterilization.
  • Collaborate with internal stakeholders and customers to align on timelines and deliverables.
  • Assess sterilization needs for new products, changes, and projects, and ensure the maintenance of the active sterilization validations as legally required.
  • Coordinate with external partners such as sterilization service providers and test laboratories, including sample management, quotation processes, and critical review of protocols and reports.
  • Maintain up-to-date knowledge of global medical device regulations, particularly ISO 11135, and apply emerging standards and methodologies in sterilization, ensuring the implementation of regulatory requirements related to the sterilization of medical devices.

Your profile:

  • Bachelor’s or Master’s degree in Engineering (preferably Biomedical, Mechanical, Natural Sciences, Biotechnology or Chemistry).
  • Minimum of 5 years of relevant experience in medical device sterilization validation, especially on EO sterilization.
  • Strong knowledge of applicable standards and regulations, including ISO 11135, ISO 13485, FDA regulations, and GMP.
  • Proven ability to manage and execute multiple projects simultaneously.
  • Capable of working both independently and collaboratively with minimal supervision.
  • Excellent problem-solving and interpersonal skills; able to communicate effectively across all organizational levels.
  • Documented sterilization training by a recognized third party or equivalent internal training by a subject-matter expert.
  • Ability to travel up to 25% of the time, both domestic and international.

Curious? Apply now!

We are interested in finding the best candidates, and they may come from a nontraditional background. So please don’t hesitate to apply, even if you aren’t an exact fit. We look forward to getting you started on your employment journey with Heraeus Medevio!

Any further questions?

Our Recruiting Team, Heraeus Medevio, is happy to assist you by email: recruiting.medevio@heraeus.com. Or visit us at jobs.heraeus.com.


ReqID: 58107
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