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Quality System Engineer (m/w)

We are looking for a highly skilled freelance Quality System Engineer (m/f) to join a global company in the medical device sector. If you're an experienced professional seeking the opportunity to work on thrilling cutting edge technology, we may have the perfect role for you.

What will you be doing?

  • AssistwiththerunningoftheCAPAsystemincludingcreatingsummaries, minutingmeetingsandcontributingtorootcauseanalysisdetermination
  • Perform Internal Audit, assist in the management of audit scheduling and updates on all related actions.
  • Assist and where appropriate lead in the compilation and execution of validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and materiel. Manage QA related change control for specific projects as directed.
  • Be responsible for the introduction and correct use of statistical QA methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
  • Assist with the maintenance of the Master Validation Plan and Critical System Changes for validated systems.
  • Review and identify potential improvements with the Leeds Quality System and products to better meet regulatory requirements.
  • Document and maintain in good order all relevant Quality assurance sections of Device Development History File and DMR as directed.
  • Co-ordinate product/technology transfer between facilities from a QA perspective. Develop and utilize DFMEA/PFMEA and other QA risk analysis techniques in order to minimize potential risk during development/implementation activity.
  • Ensure compliance with all Documented Quality system, FDA QSR's and ISO 9001 requirements during day to day and assigned audit/CAPA activities.

What skills should you have?

  • Musthave an engineeringbackground in manufacturing, with a provenabilitytointerpretandcreateengineeringspecificationsandprocedures
  • Must be PC literate, and familiar with MS Office applications.
  • Must have a good understanding of engineering drawings and geometric Tolerating.
  • Well-developed organizational skills, with ability to work on own initiative. Good communication and presentation skills in order to effectively communicate technical and QA requirements to all functional departments and external facilities.
  • Determined approach to problem solving, and ability to make appropriate decisions concerning product/process disposition and general Quality assurance procedural suitability.
  • Ability to deal with flexible workload and type is essential, and also an ability to work productively within a project focused team environment.
  • Self-motivated and self-disciplined, must be able to work unsupervised and equally well as part of a team.
  • Very good German spoken and good in written and Fluent English (spoken & written)
  • Must have experience and awareness of quality systems and techniques

Additional details

  • Location: Tuttlingen
  • Start date: as soon as possible
  • Duration: 3 months
  • Project language: German / English

Interested?
You can see yourself in this role? Get in touch, today. Please send the following documents to s.hohorst[at]realstaffing.com:


* your latest English CV as Word document
* your availability
* your hourl rate (All-in)


We are looking forward to your application.