KARL STORZ

Quality Engineer – Medical Devices

KARL STORZ

full-time

Posted on:

Location Type: Hybrid

Location: Tuttlingen • Germany

Visit company website

Explore more

✨ AI Apply
Apply

About the role

  • Define information structures: Continuously optimize information structures, documentation processes, and templates in the PLM ecosystem to ensure regulatory compliance and operational efficiency throughout the product lifecycle
  • Ensure the completeness of the DHF/DMR: Maintain a complete, accurate, and compliant Design History File (DHF) and Device Master Record (DMR). Take ownership of the Project Data Plan and Phase Gate checklists in accordance with global regulatory standards and internal quality objectives
  • Create a structured filing system: Develop and maintain a lean, transparent, and consistent project structure for all projects and immediately report any missing, time-critical elements of the DHF/DMR to the project manager
  • Develop strategies for legacy products: Provide guidelines for updating technical documentation for existing products to ensure efficient compliance
  • Prepare and conduct audits: Ensure that all project-related documents and evidence (e.g., DHF, DMR, development documentation, test reports) are complete, up-to-date, and audit-ready. Act as the primary contact for auditors, coordinate audit preparation, and represent development projects during audits
  • Ensure design traceability: Ensure that issues identified in predecessor and similar products are addressed in new product versions and that safety and quality aspects are reflected in a traceable requirements management system
  • Knowledge and implementation of standard requirements: Possess in-depth knowledge of IEC 60601-1 and relevant electronic components to ensure electrical safety, performance, and regulatory compliance of medical devices

Requirements

  • Completed degree in natural sciences or engineering
  • Proven knowledge of Design History File (DHF), Device Master Record (DMR), and global regulatory standards (e.g., ISO 13485, FDA)
  • Ability to define, optimize, and maintain information structures and documentation processes in a PLM environment
  • Ability to efficiently organize complex documentation, prepare audits, and ensure a transparent project structure
  • Confident communication skills as the contact person for auditors and project teams, including coordination of audit preparations and interdisciplinary collaboration
  • Very good English skills
Benefits
  • 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Design History File (DHF)Device Master Record (DMR)regulatory complianceinformation structuresdocumentation processesauditingrequirements managementIEC 60601-1ISO 13485FDA
Soft Skills
communication skillsorganizational skillsinterdisciplinary collaborationproject managementattention to detailproblem-solvingownershiptransparencycoordinationadaptability