Webseite Kelly Services GmbH
For our customer within the medical sector, we are searching for the location Tuttlingen a
Freelance Quality System Engineer (m/f)
This is a freelance project, start is planned for January 2019 until end of the next year.
Support the running of the CAPA system including creating summaries, minuting meetings &contributing to root cause analysis determination
Manage Internal Audits, assist in the management of audit scheduling & updates on all related actions.
Assist and, where appropriate, lead in the compilation & execution of validation protocols for new product/processes & software
Support correct implementation as per standard validation procedures
Re-validation due to engineering change, deviation analysis or upgrade in systems and materiel. Manage QA related change control for specific projects as directed.
Introduce & 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 & identify potential improvements with the Leeds Quality System and products to better meet regulatory requirements.
Document & maintain all relevant Quality assurance sections of Device Development History File & DMR
Co-ordinate product/technology transfer between facilities from a QA perspective
Develop & utilize DFMEA/PFMEA and other QA risk analysis techniques
Ensure compliance with the Quality system, FDA QSR’s and ISO 9001 requirements during day to day and assigned audit/CAPA activities.
Engineering background in manufacturing & medical systems
Experience & awareness of quality systems & techniques such as ISO9001 and SPC
Good understanding of engineering drawings & geometric Tolerating
Ability to communicate technical & QA requirements to all functional departments and external facilities
Good engineering knowledge of DFMEA, FDA QSR, PFMEA & QA
Good knowledge of Microsoft Office incl. Outlook, Word, Excel, Power Point, Access and IE
Very good German spoken and good in written and Fluent English (spoken & written)
Is this a project you would like to learn about more ? Please don’t hesitate to contact us for further inquiries: Tel: +49 40 368070 2424
Kelly Services Hamburg
T: 040 / 368070 2424
Ansprechpartner: Sarah Simon
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