HITACHI ENERGY LTD
Internship in Process Engineering(m/w/x)
VollzeitPraktikumnur vor Ort
Genf
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
INinnovative specialist spinal implant company
Process Validation Engineer - Cleanroom(m/w/x)
Plan-les-Ouates
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Cleanroom validation for spinal implants, managing IQ/OQ/PQ and environmental monitoring. Medical device validation experience required. Collaboration across R&D, Operations, and RA departments.
Anforderungen
- Proven experience in Validation and Qualification processes
- Experience in medical devices or pharmaceutical industry
- Demonstrated use of ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR 2017/745
- Experience in orthopaedic and/or spinal medical device development
- Higher qualification / degree as Quality Engineer
- Effective work in English
- Native or near-native level of French
- Strong communication skills
- Ability to clearly convey technical information
- Ability to explain complex regulatory requirements simply
- Excellent technical writing skills
- Structured documentation (protocols, reports, audit-ready records)
- Ability to manage multiple projects and validation activities
- Ability to manage under tight deadlines
- Ability to challenge decisions impacting patient safety or regulatory compliance
- Strong problem-solving skills
- Pragmatic and solution-oriented approach
- Valid driving licence
Aufgaben
- Participate in qualification-validation strategy
- Collaborate with R&D, Operations, and RA departments
- Manage cleanroom qualification activities
- Monitor environmental monitoring, requalification, and contamination control
- Coordinate validation activities (IQ/OQ/PQ) for equipment and systems
- Lead investigations and root cause analysis
- Resolve non-conformities and implement CAPA
- Ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR 2017/745
- Analyze quality metrics
- Identify opportunities for continuous improvement
- Create, review, and approve quality documentation
- Interact with auditors
- Collaborate with Production, Engineering, Regulatory Affairs, and suppliers
- Participate in DHF completeness
- Define and plan validation/verification activities
- Execute and review validation/verification activities
- Manage changes and assess impact
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Französisch – fließend
Tools & Technologien
- ISO 13485
- ISO 14971
- 21 CFR Part 820
- EU MDR 2017/745
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens innovative specialist spinal implant company 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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INinnovative specialist spinal implant company
Process Validation Engineer - Cleanroom(m/w/x)
Plan-les-Ouates
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Cleanroom validation for spinal implants, managing IQ/OQ/PQ and environmental monitoring. Medical device validation experience required. Collaboration across R&D, Operations, and RA departments.
Anforderungen
- Proven experience in Validation and Qualification processes
- Experience in medical devices or pharmaceutical industry
- Demonstrated use of ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR 2017/745
- Experience in orthopaedic and/or spinal medical device development
- Higher qualification / degree as Quality Engineer
- Effective work in English
- Native or near-native level of French
- Strong communication skills
- Ability to clearly convey technical information
- Ability to explain complex regulatory requirements simply
- Excellent technical writing skills
- Structured documentation (protocols, reports, audit-ready records)
- Ability to manage multiple projects and validation activities
- Ability to manage under tight deadlines
- Ability to challenge decisions impacting patient safety or regulatory compliance
- Strong problem-solving skills
- Pragmatic and solution-oriented approach
- Valid driving licence
Aufgaben
- Participate in qualification-validation strategy
- Collaborate with R&D, Operations, and RA departments
- Manage cleanroom qualification activities
- Monitor environmental monitoring, requalification, and contamination control
- Coordinate validation activities (IQ/OQ/PQ) for equipment and systems
- Lead investigations and root cause analysis
- Resolve non-conformities and implement CAPA
- Ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR 2017/745
- Analyze quality metrics
- Identify opportunities for continuous improvement
- Create, review, and approve quality documentation
- Interact with auditors
- Collaborate with Production, Engineering, Regulatory Affairs, and suppliers
- Participate in DHF completeness
- Define and plan validation/verification activities
- Execute and review validation/verification activities
- Manage changes and assess impact
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Französisch – fließend
Tools & Technologien
- ISO 13485
- ISO 14971
- 21 CFR Part 820
- EU MDR 2017/745
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens innovative specialist spinal implant company 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
innovative specialist spinal implant company
Branche
Healthcare
Beschreibung
The company is an innovative specialist spinal implant company committed to ethical practices and patient trust.
Noch nicht perfekt?
- HITACHI ENERGY LTD
Internship in Process Engineering(m/w/x)
VollzeitPraktikumnur vor OrtGenf - HITACHI ENERGY LTD
Internship in Process Engineering (warranty)(m/w/x)
VollzeitPraktikumnur vor OrtGenf - SQLI
System & Test (IVVQ) Engineer(m/w/x)
Vollzeitnur vor OrtSeniorGenf - Hach Lange Sàrl
Intern R&D(m/w/x)
VollzeitPraktikumnur vor OrtGenf - Selexis SA
Cell Line Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenPlan-les-Ouates