Quality Engineer for Automation & Tools (m/f/d)

Bruker; Bremen; On-site; EUR 55,000 - 75,000; Full time

Job summary

Bruker sucht in Bremen eine Quality Engineer (m/w/d) mit Fokus auf Automation und Quality Management Tools. Sie arbeiten eng mit Prozessverantwortlichen zusammen, um neue Lösungen zu entwickeln, Validierungsbedarf zu prüfen und die IT-Strategie (CRM, ERP, QMS-Tools wie MasterControl) voranzutreiben.

Sie initiieren Verbesserungen, reduzieren technische Schulden und gestalten Integrationen über APIs mit ERP/CRM-Systemen.

Qualifications

• 3+ Jahre Erfahrung mit Qualitätsmanagement-Software-Systemen.
• Erfahrung in regulierten Medizinprodukte-Umgebungen.
• Kenntnisse FDA QSR, ISO 13485, ISO 9001, IVDR.
• Validierungserfahrung (IQ, OQ, PQ).
• Projektmanagement-Erfahrung.
• Ausgezeichnete Deutsch- und Englischkenntnisse.
• Selbstmotivation und Teamfähigkeit.

Responsibilities

• Mit Prozessverantwortlichen zusammenarbeiten, neue Lösungen entwickeln und Validierungsbedarf prüfen.
• Prozesse digitalisieren und bei der Entwicklung der IT-Strategie unterstützen (CRM, ERP, QMS-Tools wie MasterControl).
• Verbesserungen initiieren; techn. Schulden abbauen.
• Integrationen: APIs verwenden, mit ERP/CRM-Systemen integrieren.
• Geschäftsprozesse durch Kennzahlen prüfen und verbessern.
• Ansprechpartner bei technischen Problemen; Fehler beheben.
• Große Tool-Wechsel verwalten (Konfig/Workflow, Import/Export, Massendaten-Update im QMS).

Skills

Quality management software

APIs integration

Copilot & AI

Project management

Deutsch & Englisch Kommunikation

Education

Sc./ B.A. in computer science oder engineering

Job description

Overview

Bruker is enabling scientists and engineers to make breakthrough post-genomic discoveries and develop new applications that improve the quality of human life. Bruker’s high-performance scientific instruments and high value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular, and microscopic levels. In close cooperation with customers, Bruker is enabling innovation and customer success in post-genomic life science molecular and cell biology, in disease biology and translational research, in specialty diagnostics, in applied and biopharma applications, as well as in industrial and cleantech research and QC, and in next-gen semiconductor metrology in support of AI. Bruker offers differentiated, high-value life science and diagnostics systems and solutions in preclinical imaging, clinical phenomics research, proteomics and multiomics, spatial and single-cell biology, functional structural and condensate biology, as well as in clinical microbiology, molecular diagnostics and therapeutic drug monitoring. For more information, please visitwww.bruker.com.

Today, more than 11000 employees at over 90 locations are working on this permanent challenge to make the world a better place.

For our quality management team in Bremen we are looking for a Quality Engineer (m/w/d) with focus on automation and tools.

Responsibilities

• Collaborate with process owners and stakeholders to develop new solutions, assess for validation needs, and ensure that the requirements are fulfilled
• Ability to digitize processes and participate in the development of the company's IT strategy (CRM, ERP, quality management tools like MasterControl, and document and record repository strategy).
• Initiate and take ownership of improvements; decrease technical debt.
• Integrations: Use APIs to integrate with other systems used in the organization, including ERP and CRM software
• Improve business processes by reviewing process efficiency metrics and suggesting improvements
• Escalation point for technical issues, troubleshooting and fixing bugs.
• Manage large scale tool changes such as configuration / workflow changes, importing, exporting, and mass updating of data in the QMS tool

Qualifications

• Sc. / B.A. in computer science, engineering, or a similar field
• Minimum 3 years of experience with quality management software systems
• Working knowledge of copilot and AI
• Multi-year (3 years) previous experience working in a regulated or medical device development environment. Knowledge of the requirements of FDA QSR, ISO 13485, and ISO 9001, IVDR, etc
• Competency in validation (NPS- IQ, OQ, PQ)
• Experience in project management
• Excellent verbal and written communication skills, in German and English
• Self motivated and improvement driven
• Capable of working in a team and collaborative work