Thoratec Switzerland GmbH
Senior Quality Engineer(m/w/x)
Vollzeitnur vor OrtSenior
Zürich
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Process validation and equipment qualification for life-saving heart failure systems. 5+ years quality engineering experience in medical devices required. Career development at a Fortune 500 company.
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Anforderungen
- Bachelor's degree in engineering, quality management, or related field
- Experience in medical devices or similar industry
- Minimum 5 years quality engineering experience
- Strong knowledge of quality management systems
- Strong knowledge of regulatory requirements
- Excellent problem-solving skills
- Experience with root cause analysis methodologies
- Proficient in quality tools and software
- Strong communication skills
- Strong interpersonal skills
- Effective teamwork skills
- In-depth process validation experience
- In-depth test method validation experience
- Application of statistical methods
- Experience with CAPA processes
- Proficiency in written German
- Proficiency in spoken German
- Proficiency in written English
- Proficiency in spoken English
Aufgaben
- Collaborate with Manufacturing Engineering for process validation and equipment qualification.
- Evaluate, review, and approve validation and qualification plans, reports, and risk files.
- Manage non-conforming material (NCMR) handling.
- Develop and implement corrective and preventive actions (CAPA) based on NCMR findings.
- Document, track, and trend NCMRs, ensuring timely and effective corrections.
- Collaborate with cross-functional teams to resolve non-conformance issues and prevent recurrence.
- Lead root cause analysis and problem-solving activities for quality issues.
- Investigate and resolve non-conformances.
- Drive the CAPA process to identify root causes of quality issues, implement corrective actions, and verify their effectiveness.
- Develop preventive measures to avoid recurrence.
- Analyze and report trends and statistical data from investigations with Manufacturing Engineering and company management.
- Participate in internal and external audits, providing necessary documentation and support.
- Act as an NCMR Subject Matter Expert (SME) during audits.
- Work closely with cross-functional teams to address quality-related issues.
- Champion continuous improvement initiatives within the quality department.
- Implement best practices and innovative solutions to enhance product quality and process efficiency.
Berufserfahrung
5 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Deutsch – verhandlungssicher
Englisch – verhandlungssicher
Benefits
Karriere- und Weiterentwicklung
- Career development
Sonstige Vorteile
- Fortune 500 company
- World's leading medical device manufacturer
- Highly educated team
- Highly skilled team
Sicherer Arbeitsplatz
- Crisis independent industry
Startup-Atmosphäre
- Dynamic team
Lockere Unternehmenskultur
- Motivated team
- Multi-national environment
Weiterbildungsangebote
- Talent development within enterprise
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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