Werner Turck GmbH & Co. KG
Leiter Qualitätssicherung(m/w/x)
Vollzeitmit HomeofficeManagement
Halver
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
SGSGS
Global Head of Operations(m/w/x)
Meinerzhagen
VollzeitRemoteSenior
Nejo KI-Zusammenfassung
Optimizing certification operating models and leading medical schemes line managers. Strong understanding of EU MDR, IVDR, and ISO 13485 required. Flexible schedule, hybrid model, and continuous learning campus.
Anforderungen
- Strong understanding of EU MDR, EU IVDR, UKCA, MDSAP, ISO 13485, notified body operational requirements
- In-depth knowledge of conformity assessment delivery models and processes
- Proven experience building and managing teams in regulated environment
- Expertise in capacity planning, resource optimisation, performance management
- Excellent organisational, analytical, change-management skills
- Excellent stakeholder management and communication skills
- Ability to balance regulatory compliance with business efficiency
- Experience within Notified Body or equivalent conformity assessment organisation
- Minimum 10 years experience in medical device or IVD industry
- At least 5 years in technical leadership role within Notified Body
- Demonstrated success in scaling operations and improving operational performance
- Experience working within Notified Body or equivalent regulatory organisation
- 5+ years experience in Notified Body, manufacturing or other regulated industries
- 5+ years leadership experience
- Qualification as Lead Auditor or Senior Product Assessor under EU MDR/EU IVDR
- Qualification as Final Reviewer and/or Decision Maker under MDR or IVDR, desirable
- University degree in medicine, engineering, or life sciences
- CV in English
Aufgaben
- Lead all line managers in Operations for Medical Schemes
- Optimize the operating model for certification activities
- Oversee operational performance management and reporting
- Manage operational financial performance and cost control
- Develop resource strategy and long-term workforce planning
- Maintain competence management and training frameworks
- Manage operational risks and business continuity planning
- Liaise for designation maintenance and regulatory inspections
- Monitor and respond to regulatory changes and industry trends
- Contribute to the Global Medical Leadership team
- Initiate and deliver projects proactively
- Ensure regulatory, commercial, and operational alignment
- Lead continuous improvement initiatives
- Collaborate with line managers for seamless contract delivery
- Support recruitment and onboarding of personnel
- Ensure compliance with SGS integrity policies
- Maintain strong relationships with stakeholders
- Secure resources for conformity assessment activities
- Drive standardization and harmonization of processes
- Account for notified body activities and decisions
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
Tools & Technologien
- EU MDR
- EU IVDR
- UKCA
- MDSAP
- ISO 13485
Benefits
Flexibles Arbeiten
- Flexible schedule
- Hybrid model
Weiterbildungsangebote
- SGS university
- Campus for continuous learning
Mitarbeiterrabatte
- Benefits platform
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens SGS 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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SGSGS
Global Head of Operations(m/w/x)
Meinerzhagen
VollzeitRemoteSenior
Nejo KI-Zusammenfassung
Optimizing certification operating models and leading medical schemes line managers. Strong understanding of EU MDR, IVDR, and ISO 13485 required. Flexible schedule, hybrid model, and continuous learning campus.
Anforderungen
- Strong understanding of EU MDR, EU IVDR, UKCA, MDSAP, ISO 13485, notified body operational requirements
- In-depth knowledge of conformity assessment delivery models and processes
- Proven experience building and managing teams in regulated environment
- Expertise in capacity planning, resource optimisation, performance management
- Excellent organisational, analytical, change-management skills
- Excellent stakeholder management and communication skills
- Ability to balance regulatory compliance with business efficiency
- Experience within Notified Body or equivalent conformity assessment organisation
- Minimum 10 years experience in medical device or IVD industry
- At least 5 years in technical leadership role within Notified Body
- Demonstrated success in scaling operations and improving operational performance
- Experience working within Notified Body or equivalent regulatory organisation
- 5+ years experience in Notified Body, manufacturing or other regulated industries
- 5+ years leadership experience
- Qualification as Lead Auditor or Senior Product Assessor under EU MDR/EU IVDR
- Qualification as Final Reviewer and/or Decision Maker under MDR or IVDR, desirable
- University degree in medicine, engineering, or life sciences
- CV in English
Aufgaben
- Lead all line managers in Operations for Medical Schemes
- Optimize the operating model for certification activities
- Oversee operational performance management and reporting
- Manage operational financial performance and cost control
- Develop resource strategy and long-term workforce planning
- Maintain competence management and training frameworks
- Manage operational risks and business continuity planning
- Liaise for designation maintenance and regulatory inspections
- Monitor and respond to regulatory changes and industry trends
- Contribute to the Global Medical Leadership team
- Initiate and deliver projects proactively
- Ensure regulatory, commercial, and operational alignment
- Lead continuous improvement initiatives
- Collaborate with line managers for seamless contract delivery
- Support recruitment and onboarding of personnel
- Ensure compliance with SGS integrity policies
- Maintain strong relationships with stakeholders
- Secure resources for conformity assessment activities
- Drive standardization and harmonization of processes
- Account for notified body activities and decisions
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
Tools & Technologien
- EU MDR
- EU IVDR
- UKCA
- MDSAP
- ISO 13485
Benefits
Flexibles Arbeiten
- Flexible schedule
- Hybrid model
Weiterbildungsangebote
- SGS university
- Campus for continuous learning
Mitarbeiterrabatte
- Benefits platform
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens SGS 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
SGS
Branche
Consulting
Beschreibung
Das Unternehmen ist das weltweit führende Unternehmen in den Bereichen Prüfen, Inspizieren und Zertifizieren.
Noch nicht perfekt?
- Werner Turck GmbH & Co. KG
Leiter Qualitätssicherung(m/w/x)
Vollzeitmit HomeofficeManagementHalver - BGS Beta-Gamma-Service GmbH & Co. KG
Standortübergreifende Leitung Instandhaltung Medizintechnik(m/w/x)
Vollzeitmit HomeofficeSeniorWiehl - Viega
Global Category Manager - Maschinenbeschaffung(m/w/x)
Vollzeitmit HomeofficeSeniorAttendorn - Chart Industries
EHS Manager(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenOlpe - Viega
Expert Business Processes Supply Chain(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenAttendorn