Subject Matter Expert for Sterilisation Medical Products (m / f / d)

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Summary

The Flow & Fluid Sterilization specialist is responsible for all sterilization and sterilization validation activities for our disposable business. The Sterilization specialist has the technical lead of our Sterilization Board. The Sterilization specialist is also responsible for the midterm and long-term sterilization strategy.

Primary Responsibilities

• Subject Matter Expert for Sterilization (flow & fluid) internal and external to FDA, TÜV, Customer, Sterilization Service Provider, Labs etc.
• Head of our Sterilization Board, coordinating all tasks of the Sterilization Board, creating project plans to publish the tasks of the Sterilization Board for resource balancing, allocating sufficient capacities for all sterilization tasks, doing the basic training of colleagues (System Engineers and Architects, Project Managers…)
• Member of our Standards Committee, evaluation of changes to standards, derive corresponding measures for Flow & Fluid
• Development of a midterm and long-term sterilization strategy for all NPI and series products for cost savings and EHS
• Sterilization validation for NPI products, sterilization revalidation, writing protocols, reports, adoption reports, statements and white papers. Review and release of internal and external protocols and reports.
• Routine sterilization of all series products, revalidation, evaluation of NCs, support release of serial production after sterilization
• Monitoring, qualifying, and approving process changes at sterilization service providers.
• Guarantee sufficient sterilization capacity for series production demand.
• Qualification of new sterilization service providers if required.

General Tasks

• Strict compliance with quality, occupational safety, and environmental regulations.
• Implementation of the instructions of the quality / environmental management representative and the occupational safety specialist.

Required Experience, Education, Skills, Training and Competencies

• Several years of sterilization process experience of medical disposable products
• Knowledge of all sterilization methods and sterilization standards and guidelines
• Familiar with all relevant regulations
• Independent and interdisciplinary solution finding with more than 10 team members.
• SAP knowledge preferable

Travel Requirements

• Willingness to travel to all locations and business contacts

Physical Requirements

• Quality-conscious, trustworthy, and reliable
• Team player
• Structured and systematic way of working

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