QM Process Specialist

• 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 review 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, 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.
• 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 a 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.
• 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.

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