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 roll-out
* 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 cross-site activities to resolve business critical issues in the marketplace (e.g. complaints, CAPA's, 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, non-conformities, CAPA and Audit as well as basic understanding of handling quality topics in a production environment
* In-depth 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
* Capital-forming benefits
* Performance-related 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!