QM Process Specialist
QM Process Specialist
Posted on :
09-05-2025
Employer Active
1 Vacancy
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Job Description
- Support with the implementation of our global QMS and act as ambassador for it by delivering trainings to the users
- Write global policies taking into account lean and least burdensome principles and applicable laws standards and internal requirements. Ensure alignment with site responsible functions prior to rollout
- Help to create and structure the global process landscape gathering feedback and continuously analyzing improvement needs
- Coach local process owners in interpreting global process expectations support process owners with process issues/problems and reviewing for improvement opportunities
- Ensure consistent and timely quality KPI reporting at global and BU level collect and review site KPI information for consistency of data and trends
- Assist the Quality Managers in defining data sources related to quality KPI reporting
- Support Global and Local Quality Management as requested in crosssite activities to resolve business critical issues in the marketplace (e.g. complaints CAPAs audits or similar)
- Act as Business Application Owner for medmix document management system
Qualifications :
- University degree in technical engineering or life sciences or higher specialized training in a technical or scientific field with extended training in standards and tools relevant to quality management
- Experience in Quality Management in the field of Medical Devices
- Extensive practical experience of handling typical quality tools like complaints nonconformities CAPA and Audit as well as basic understanding of handling quality topics in a production environment
- Indepth experience with laws and standards related to Medical Devices (e.g. ISO 13485 MDR QSR.)
- Proficient experience in implementing and adapting software tools (ERP MES CAQ and DMS Excel) for quality purposes
- Proven ability to easily convey complex relationships to different audiences
- Very good knowledge of written and spoken English and German (C1 Level for both)
- Flexibility in daily working hours as required to accommodate different time zones for online collaboration
Additional Information :
- Working in highly motivated international team with dedicated people who put the needs of patients at the center of their doing
- Flexible hybrid working environment
- 30 days vacation
- Pluxee Card Benefits
- Company pension plan
- Capitalforming benefits
- Performancerelated salary many attractive social benefits and a flexible and modern international working environment
medmix is an equal opportunity employer committed to the strength of a diverse workforce.
93% of our employees would go above and beyond to deliver results do you have the drive to succeed Join us and boost your career starting today!
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
Key Skills
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