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KA
Karl Storz SE & Co. KG
2mo ago

Quality Engineer Medical Devices(m/w/x)

Tuttlingen
Full-timeWith Home Office

Description

You will ensure the safety of life-saving medical devices by managing complex technical documentation and audit readiness while optimizing regulatory processes and structures.

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Requirements

  • Degree in natural sciences or engineering
  • Knowledge of DHF, DMR, and regulatory standards
  • Management of PLM information structures
  • Organization of complex documentation and audits
  • Confident coordination of audits and teams
  • Very good English skills
  • Knowledge of IEC 60601-1 and electronic components

Education

Bachelor's degree

Tasks

  • Optimize information structures and documentation processes
  • Maintain compliant DHF and DMR records
  • Manage Project Data Plans and Phase Gate checklists
  • Develop lean and transparent project filing systems
  • Report time-critical missing documentation to project managers
  • Create guidelines for updating legacy product documentation
  • Prepare and coordinate comprehensive audit documentation
  • Act as the primary contact for auditors
  • Represent development projects during audits
  • Ensure design traceability and requirements management
  • Integrate safety and quality aspects into new versions
  • Implement IEC 60601-1 standards for electrical safety

Tools & Technologies

Design History File (DHF)Device Master Record (DMR)ISO 13485FDAPLMIEC 60601-1

Languages

EnglishBusiness Fluent

Benefits

Flexible Working

  • Hybrid work
  • Flexible working hours
  • Mobile working

More Vacation Days

  • 30 vacation days

Additional Allowances

  • Various special payments

Learning & Development

  • In-house seminar program
  • Extensive e-learning offering
  • Professional development courses

Company Bike

  • Bicycle leasing

Retirement Plans

  • Private pension plan subsidy

Healthcare & Fitness

  • Company health management
  • Health activities
  • Sports activities

Childcare

  • Various childcare options

Team Events

  • Cultural activities
  • Leisure activities
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