Thoratec Switzerland GmbH
.Quality Engineer(m/w/x)
Vollzeitnur vor OrtSenior
Zürich
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Implementing production quality assurance for advanced heart pump systems. 5+ years in regulated industry quality role, validation experience required. Supplier audit experience preferred.
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Anforderungen
- Bachelor or Master degree in Science, Engineering, or technical field
- Minimum 5 years in medical-device manufacturing or regulated industry quality role
- Experience conducting or reviewing validations
- Supplier audit experience preferred
- Certified body audit and inspection experience preferred
- Experience with change management and quality systems
- ISO 9001 and/or ISO 13485 auditor certification preferred
- Performing supplier audits and managing supplier quality
- Strong analytical skills with data reporting and dashboard creation
- Familiarity with international and domestic medical-device regulatory guidelines
- Strong communication skills in English (written and spoken)
- Excellent organizational, time management, and problem-solving skills
- Initiative, self-responsibility, and ownership
- Curiosity, motivation, and desire to grow and make a difference
Aufgaben
- Implement production quality assurance
- Document control activities
- Ensure compliance with internal procedures
- Ensure compliance with international regulations
- Execute quality organization activities
- Ensure product quality, performance, and safety
- Support Operations and external suppliers
- Resolve quality issues
- Drive Quality Systems goals
- Ensure facility-wide compliance
- Analyze quality metrics and trends
- Report quality metrics and trends
- Develop quality data dashboards
- Maintain quality data dashboards
- Present quality data dashboards
- Resolve supplier issues
- Escalate supplier issues
- Coordinate corrective actions with suppliers
- Manage supplier non-conformances
- Perform supplier site audits
- Ensure supplier compliance
- Manage supplier qualification documentation
- Oversee supplier validations
- Manage supplier-related KPI reporting
- Support change control processes
- Assess changes
- Approve changes
- Implement changes
- Check change effectiveness
- Support quality assurance procedures
- Review supplier change notifications
- Manage supplier change notifications
- Conduct timely risk assessments
- Ensure cross-functional alignment
- Ensure proper approval and implementation
- Support certified bodies
- Support internal audits
- Analyze trends
- Determine root causes
- Implement CAPA actions
- Perform additional tasks assigned by QA management
Berufserfahrung
5 Jahre
Ausbildung
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Deutsch – Grundkenntnisse
Tools & Technologien
ISO 9001ISO 13485
Benefits
Karriere- und Weiterentwicklung
- Career growth opportunities
Sicherer Arbeitsplatz
- Stable and future-focused industry
Lockere Unternehmenskultur
- Collaborative and inclusive team culture
Modernes Büro
- Modern workplace
Sonstige Vorteile
- Valued perspectives and experiences
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Thoratec Switzerland GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei Thoratec Switzerland GmbHÜber das Unternehmen
TH
HealthcareZürich
The company is a global leader in life-saving medical technologies, supporting patients with advanced heart failure.
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