Project Manager eQMS | Project Manager eQMS (m/w/d)
Orizon GmbH, Niederlassung Ostwürttemberg
Job Summary
We are seeking a Project Manager to lead the digitalization of our Quality Management System (QMS) by implementing an electronic QMS (eQMS). This role involves developing the overall concept, creating project and quality plans, and managing the selection and implementation of eQMS tools. You will be responsible for gathering user requirements, conducting market research, and ensuring the chosen solution meets predefined needs. Key tasks include planning implementation, managing outsourcing, defining acceptance criteria, and overseeing CSV activities. You will also develop training materials, create process documentation, and ensure compliance with standards like ISO 13485, 21 CFR Part 11, and EU MDR. The position requires strong collaboration with IT for seamless integration. This is an attractive opportunity to shape a critical digital transformation within a leading medical technology company.
Required Skills
Education
Master's degree in Data Management, Engineering, or a comparable qualification. Alternatively, a completed degree in Business Informatics, Computer Science, Industrial Engineering, Business Administration, or a comparable field of study.
Experience
- Minimum 10 years of experience in the implementation and application of QMS software systems within the medical technology industry.
- Additional experience in the pharmaceutical industry is advantageous.
- Proven experience in successfully leading a large, cross-functional project in the QMS area, ideally involving software implementation.
- Professional experience in project management.
- Professional experience in process design and optimization.
- Strong experience in interface management.
Languages
Additional
- {"Willingness to travel."}
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