QM Process Specialist
QM Process Specialist
Posted on :
16-04-2025
Employer Active
1 Vacancy
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Job Description
- 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
- Act as ambassador of a global QMS through training
- 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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