Thoratec Switzerland GmbH
Manager NPI Engineering(m/w/x)
Vollzeitnur vor OrtSenior
Zürich
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
THThoratec Switzerland GmbH
Manager Quality System & Regulatory Compliance(m/w/x)
Zürich
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Overseeing ISO 13485 and FDA 21 CFR Part 820 compliance for blood pump systems. 3-5 years of medical device quality systems leadership experience required. Collaborative, international work environment with flat hierarchies.
Anforderungen
- Master’s degree in science, engineering, or technical discipline
- 3–5 years experience in quality systems (medical device or regulated environment)
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDD/MDR, MDSAP
- Experience leading teams in regulated setting
- Strong English and German communication skills
- Attention to detail and pragmatic mindset
- Enjoy developing people and team performance
- Comfortable influencing in a matrix organization
- High ethical standards and ownership
- Encouraged to apply if not meeting every requirement
Aufgaben
- Lead and develop Quality System specialists
- Set clear goals aligned with company and regulatory objectives
- Foster a collaborative and inclusive team environment
- Support team performance through coaching and feedback
- Ensure effective execution of Quality Management Systems
- Maintain compliance with international standards (ISO 13485, FDA QSR, EU MDR)
- Prepare for and support external audits and inspections
- Partner with Operations, R&D, Engineering, and Regulatory Affairs
- Identify and implement process improvement opportunities
- Lead or contribute to global quality initiatives
- Drive corrective and preventive actions (CAPA)
- Conduct root cause analysis and develop sustainable solutions
- Operate in a matrixed, international environment
- Build trusted relationships with stakeholders
- Communicate clearly to technical and non-technical audiences
Berufserfahrung
- 3 - 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- ISO 13485
- FDA 21 CFR Part 820
- EU MDD/MDR
- MDSAP
Benefits
Sinnstiftende Arbeit
- Meaningful work
Sicherer Arbeitsplatz
- Stable and growing company
- Resilient industry
Lockere Unternehmenskultur
- Collaborative, respectful, and international working environment
- Flat hierarchies
- Open and transparent communication
Weiterbildungsangebote
- Personal and professional development opportunities
Modernes Büro
- Modern workplace in Zurich center
Sonstige Vorteile
- On-site R&D and manufacturing
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. 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.
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Vollzeitnur vor OrtSeniorSchlieren
THThoratec Switzerland GmbH
Manager Quality System & Regulatory Compliance(m/w/x)
Zürich
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Overseeing ISO 13485 and FDA 21 CFR Part 820 compliance for blood pump systems. 3-5 years of medical device quality systems leadership experience required. Collaborative, international work environment with flat hierarchies.
Anforderungen
- Master’s degree in science, engineering, or technical discipline
- 3–5 years experience in quality systems (medical device or regulated environment)
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDD/MDR, MDSAP
- Experience leading teams in regulated setting
- Strong English and German communication skills
- Attention to detail and pragmatic mindset
- Enjoy developing people and team performance
- Comfortable influencing in a matrix organization
- High ethical standards and ownership
- Encouraged to apply if not meeting every requirement
Aufgaben
- Lead and develop Quality System specialists
- Set clear goals aligned with company and regulatory objectives
- Foster a collaborative and inclusive team environment
- Support team performance through coaching and feedback
- Ensure effective execution of Quality Management Systems
- Maintain compliance with international standards (ISO 13485, FDA QSR, EU MDR)
- Prepare for and support external audits and inspections
- Partner with Operations, R&D, Engineering, and Regulatory Affairs
- Identify and implement process improvement opportunities
- Lead or contribute to global quality initiatives
- Drive corrective and preventive actions (CAPA)
- Conduct root cause analysis and develop sustainable solutions
- Operate in a matrixed, international environment
- Build trusted relationships with stakeholders
- Communicate clearly to technical and non-technical audiences
Berufserfahrung
- 3 - 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- ISO 13485
- FDA 21 CFR Part 820
- EU MDD/MDR
- MDSAP
Benefits
Sinnstiftende Arbeit
- Meaningful work
Sicherer Arbeitsplatz
- Stable and growing company
- Resilient industry
Lockere Unternehmenskultur
- Collaborative, respectful, and international working environment
- Flat hierarchies
- Open and transparent communication
Weiterbildungsangebote
- Personal and professional development opportunities
Modernes Büro
- Modern workplace in Zurich center
Sonstige Vorteile
- On-site R&D and manufacturing
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. 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.
Über das Unternehmen
Thoratec Switzerland GmbH
Branche
Healthcare
Beschreibung
The company is a global leader in life-saving medical technologies, supporting patients with advanced heart failure.
Noch nicht perfekt?
- Thoratec Switzerland GmbH
Manager NPI Engineering(m/w/x)
Vollzeitnur vor OrtSeniorZürich - ThoratecSwitzerland GmbH
Change Control Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenZürich - NL3M Philips International BV
Patient Safety and Quality Leader DACH(m/w/x)
Vollzeitnur vor OrtManagementHorgen - The Kusnacht Practice AG
Clinical Quality, Process & Medical Procurement Specialist(m/w/x)
Vollzeitnur vor OrtSeniorZollikon - SIEGFRIED DiNAMIQS AG
QA Specialist(m/w/x)
Vollzeitnur vor OrtSeniorSchlieren