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Product Quality Engineering

vor 3 Monaten

Zug, Zug, Schweiz ITech Consult AG Vollzeit

Product Quality Engineering (m/w/d)- Serien-produktion/ Quality Assurance/Qualitätstechnik/ Prüfplanung / GxP / Medizinaltechnik oder IVD (ISO 13485, FDA 21 CFR 820, IVDR/MDR)/ Englisch/ Deutsch

Projekt:
Für unseren Kunden Roche Diagnostics International AG mit Sitz in Rotkreuz suchen wir einen Product Quality Engineering (m/w/d).

Background:
Instrument Operations Rotkreuz gewährleistet die Produktion und Verwaltung eines komplexen Portfolios von kleinen bis großen Analysesystemen. Innerhalb dieser Organisation ist die Abteilung Production Engineering eine Support-Abteilung mit 6 verschiedenen Teams, welche die Montage, die Qualitätskontrolle sowie die technische Freigabe und die Verpackung der Diagnostik Geräte unterstützt. Unser Ziel ist es, dass die Produktion bestmöglich unterstützt wird, um reibungslose Abläufe, höchste Qualität und Quantität sicherzustellen. Als eines dieser 6 Teams sind die QC Product Quality Engineers für die Sicherstellung und Überprüfung der Produktqualität zuständig.

Der oder die perfekte Kandidat:in ist eine Person mit einem sehr hohen Qualitätsbewusstsein, die Freude an der Arbeit mit unterschiedlichsten Schnittstelen in einer grossen Organisation hat und für die exakte Dokumentation selbstverständlich ist. Technisches Know How und Wissen zur Labordiagnostik gehören ebenso zu den Kompetenzen wie die Fähigkeit im Umgang mit stressigen Situationen.

Tasks & Responsibilities:

• Sicherstellung und Überprüfung der Produktqualität der zugewiesenen Produkte über die gesamte Montage- Prüfkette

• Fachliche Freigabe der zugewiesenen Produkte und Einleitung der Eskalation im Fall von fehlerhaften Produkten

• Bearbeitung und fachlicher Review von Abweichungen (z.B. Q-Meldungen)

• Koordination von Q-Meldungen zur Abwicklung von Lieferantenfehlern, die innerthalb der Produktion aufgekommen sind

• Verantwortlich für die Auswertung und Analyse von Qualitätsdaten sowie regelmässiges Durchführen des Produkt Qualität Meetings

• Erstellung, Aktualisierung, Review und Schulung von Vorgabedokumenten, Anweisungen und Berichten sowie fachlicher Review von Validierungs- und Qualifizierungsunterlagen

• Bearbeitung von spezifischen CAPA sowie ECR-Tasks

• Systemeigner von Prüfplätzen, Verantwortlich für die Kalibration/Wartung von Equipments sowie die Erstellung relevanter Dokumente

• Umsetzung von KVP (kontinuierlicher Verbesserungsprozess) Massnahmen

Must Haves:

• ENTWEDER Hochschul- oder Fachhochschulabschluss in Medizintechnik / Maschinenbau / vergleichbare technische Richtung ODER technische Grundausbildung (EFZ) im Bereich Werkzeugbau, Polymechaniker o.ä. mit praktischer Erfahrung im Qualitätswesen oder im diagnostischen / molekularbiologischen Labor von Vorteil.

• Erste Berufserfahrung / Mind. 1 Jahr Berufserfahrung in Serien-produzierenden Unternehmen

• Erste Berufserfahrung / Mind. 1 Jahr Berufserfahrung im Bereich Quality Assurance, Qualitätstechnik, Prüfplanung (GxP Umfeld)

• Praxiserfahrung im regulierten GxP-Umfeld, idealerweise der Medizinaltechnik oder IVD (ISO 13485, FDA 21 CFR 820, IVDR/MDR)

• Sehr gute Kommunikationsfähigkeiten in Deutsch und Englisch (Wort und Schrift) wird vorausgesetzt

Nice to Have:

• Praktische Erfahrung in der Anwendung der Six Sigma-Methodik

• Erfahrung in der Handhabung von Complaint- und Abweichungsmeldungen

• Vertiefte EDV Kenntnisse (SAP; Tableau; statistische Analytik)

• Ausgeprägtes Stakeholder- und Erwartungsmanagment in interdisziplinären Teams

• Erfahrung in einer stark regulierten Produktionsumgebung

• Fachkenntnisse aus der Molekularbiologie, im speziellen der Sequenzierung

Reference Nr.: 923452SDA
Role: Product Quality Engineering
Industrie: Pharma
Workplace: Rotkreuz
Pensum: 50-60%
Start: ASAP
Duration: 12++
Deadline:

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme:

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge yo any additional fees.