QM Process Specialist

medmix; Stuttgart; Hybrid; EUR 50.000 - 90.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen sucht einen Qualitätsmanagement-Experten, der globale Richtlinien erstellt und die Qualität in einem internationalen Team sicherstellt. In dieser spannenden Rolle sind Sie verantwortlich für die Unterstützung lokaler Qualitätsmanager und die Umsetzung von Qualitätstools. Sie arbeiten in einem flexiblen hybriden Umfeld, das auf die Bedürfnisse der Patienten fokussiert ist. Wenn Sie eine Leidenschaft für Qualität und eine internationale Zusammenarbeit haben, ist dies die perfekte Gelegenheit, Ihre Karriere zu fördern und einen Unterschied zu machen.

Leistungen

30 Tage Urlaub

Pluxee Card Vorteile

Betriebliche Altersvorsorge

Leistungsbezogenes Gehalt

Attraktive Sozialleistungen

Qualifikationen

• Erfahrung im Qualitätsmanagement im Bereich Medizinprodukte erforderlich.
• In-depth Erfahrung mit Gesetzen und Standards im Zusammenhang mit Medizinprodukten.

Aufgaben

• Erstellung globaler Richtlinien unter Berücksichtigung von Gesetzen und Standards.
• Coaching lokaler Prozessverantwortlicher und Unterstützung bei Prozessproblemen.

Kenntnisse

Qualitätsmanagement

Kommunikationsfähigkeiten

Flexibilität

Analytische Fähigkeiten

Ausbildung

Universitätsabschluss in Ingenieurwissenschaften oder Lebenswissenschaften

Spezialisierte Ausbildung in Qualitätsmanagement

Tools

ERP-Systeme

MES

CAQ

DMS

Excel

Jobbeschreibung

• 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.

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: Employment Type:

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