Becton Dickinson
Senior Clinical Project Manager(m/w/x)
Vollzeitmit HomeofficeSenior
Karlsruhe
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
DEDE09 Agilent Technologies Deutschland GmbH
Lead Internal Auditor – Global Quality(m/w/x)
Waldbronn
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Leading risk-based internal audits of QMS compliance for medical device and pharma operations. 8+ years in regulated quality systems and internal auditing required. Audit strategy development, complex multi-site audits.
Anforderungen
- Bachelor’s degree in science, engineering, or related field
- Advanced degree preferred
- 8+ years’ experience in regulated quality systems
- 8+ years’ experience in internal auditing
- 8+ years’ experience in regulatory compliance
- Experience in pharmaceutical and/or medical device industries
- 5+ years’ experience as Lead Internal Auditor
- Audit planning experience
- Audit execution experience
- Auditor management experience
- ISO 13485 Lead Auditor certification
- Experience auditing full product lifecycle
- Experience auditing design processes
- Experience auditing manufacturing processes
- Experience auditing laboratories
- Experience auditing post-market surveillance
- Experience auditing support processes
- Strong analytical skills
- Strong risk-based thinking skills
- Strong problem-solving skills
- Strong communication skills
- Ability to influence across global matrix organizations
- Proven ability to manage multiple audits
- Proven ability to manage multiple priorities
- Maintain professionalism during audits
- Maintain integrity during audits
- Maintain sound judgment during audits
- Willingness to travel globally up to 50%
Aufgaben
- Plan and lead risk-based internal audits
- Conduct audits in pharmaceutical and medical device operations
- Serve as Lead Auditor for complex, cross-functional, and multi-site audits
- Assess QMS compliance with ISO 9001, ISO 13485, FDA cGMP/QSR, EU GMP, IVDR, and ICH requirements
- Develop audit strategies, plans, and reports
- Communicate audit findings, trends, and improvement opportunities
- Identify systemic issues and drive continuous improvement
- Provide guidance on regulatory and quality requirements
- Train and coach sites on self-directed audits
- Support inspection and audit readiness activities
- Prepare for regulatory authority inspections and Notified Body audits
- Assist with nonconformity and observation responses
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens DE09 Agilent Technologies Deutschland 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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DEDE09 Agilent Technologies Deutschland GmbH
Lead Internal Auditor – Global Quality(m/w/x)
Waldbronn
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Leading risk-based internal audits of QMS compliance for medical device and pharma operations. 8+ years in regulated quality systems and internal auditing required. Audit strategy development, complex multi-site audits.
Anforderungen
- Bachelor’s degree in science, engineering, or related field
- Advanced degree preferred
- 8+ years’ experience in regulated quality systems
- 8+ years’ experience in internal auditing
- 8+ years’ experience in regulatory compliance
- Experience in pharmaceutical and/or medical device industries
- 5+ years’ experience as Lead Internal Auditor
- Audit planning experience
- Audit execution experience
- Auditor management experience
- ISO 13485 Lead Auditor certification
- Experience auditing full product lifecycle
- Experience auditing design processes
- Experience auditing manufacturing processes
- Experience auditing laboratories
- Experience auditing post-market surveillance
- Experience auditing support processes
- Strong analytical skills
- Strong risk-based thinking skills
- Strong problem-solving skills
- Strong communication skills
- Ability to influence across global matrix organizations
- Proven ability to manage multiple audits
- Proven ability to manage multiple priorities
- Maintain professionalism during audits
- Maintain integrity during audits
- Maintain sound judgment during audits
- Willingness to travel globally up to 50%
Aufgaben
- Plan and lead risk-based internal audits
- Conduct audits in pharmaceutical and medical device operations
- Serve as Lead Auditor for complex, cross-functional, and multi-site audits
- Assess QMS compliance with ISO 9001, ISO 13485, FDA cGMP/QSR, EU GMP, IVDR, and ICH requirements
- Develop audit strategies, plans, and reports
- Communicate audit findings, trends, and improvement opportunities
- Identify systemic issues and drive continuous improvement
- Provide guidance on regulatory and quality requirements
- Train and coach sites on self-directed audits
- Support inspection and audit readiness activities
- Prepare for regulatory authority inspections and Notified Body audits
- Assist with nonconformity and observation responses
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens DE09 Agilent Technologies Deutschland 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
DE09 Agilent Technologies Deutschland GmbH
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen bietet Geräte, Software, Dienstleistungen und Verbrauchsmaterialien für analytische Labore und trägt zur Verbesserung der Lebensqualität bei.
Noch nicht perfekt?
- Becton Dickinson
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