Quality System Engineer - Medical devices - Tuttlingen (GOE-106762)

Tuttlingen  ‐ Vor Ort
Dieses Projekt ist archiviert und leider nicht (mehr) aktiv.
Sie finden vakante Projekte hier in unserer Projektbörse.

Beschreibung

Task:
• Be involved in the running of the CAPA system including creating summaries, minuting meetings and contributing to root cause analysis determination
• Perform Internal Audit, assist in the management of audit scheduling and updates on all related actions.
• Compilation and execution of validation protocols for new product/processes and software.
• Ensure correct implementation as per standard validation procedures. Revalidate 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.
• Be involved 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.
• Coordinate 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.

Requirements (Must have):
• Experience and awareness of quality systems and techniques such as ISO9001 and SPC.
• Engineering background in manufacturing, with a proven ability to interpret and create engineering specifications and procedures
• PC literate, and familiar with MS Office applications.
• Very good German spoken and good in written and Fluent English (spoken & written)

Nice to have:
• Experiences with DFMEA, PFMEA and FDA

Environment/Miscellaneous:
• full-time onsite

Beginn: 03.01.2019
Dauer: 31.12.2019
Branche: Medizin/Healthcare
Start
01.2019
Dauer
12 Monate
Von
Allgeier Experts Consulting GmbH
Eingestellt
27.11.2018
Ansprechpartner:
Tobias Trockel
Projekt-ID:
1674505
Vertragsart
Freiberuflich
Um sich auf dieses Projekt zu bewerben müssen Sie sich einloggen.
Registrieren