Werner Turck GmbH & Co. KG
Leiter Qualitätssicherung(m/w/x)
Full-timeWith HomeofficeManagement
Halver
New Job?Nejo!
Your personal AI career agent
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Native
Tools & Technologies
- EU MDR
- EU IVDR
- UKCA
- MDSAP
- ISO 13485
Benefits
Flexible Working
- Flexible schedule
- Hybrid model
Learning & Development
- SGS university
- Campus for continuous learning
Corporate Discounts
- Benefits platform
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SGS and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
- BGS Beta-Gamma-Service GmbH & Co. KG
Standortübergreifende Leitung Instandhaltung Medizintechnik(m/w/x)
Full-timeWith HomeofficeSeniorWiehl - Viega
Global Category Manager - Maschinenbeschaffung(m/w/x)
Full-timeWith HomeofficeSeniorAttendorn - Viega
Expert Business Processes Supply Chain(m/w/x)
Full-timeWith HomeofficeExperiencedAttendorn - Chart Industries
EHS Manager(m/w/x)
Full-timeWith HomeofficeExperiencedOlpe
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Native
Tools & Technologies
- EU MDR
- EU IVDR
- UKCA
- MDSAP
- ISO 13485
Benefits
Flexible Working
- Flexible schedule
- Hybrid model
Learning & Development
- SGS university
- Campus for continuous learning
Corporate Discounts
- Benefits platform
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SGS and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
SGS
Industry
Consulting
Description
Das Unternehmen ist das weltweit führende Unternehmen in den Bereichen Prüfen, Inspizieren und Zertifizieren.
Not a perfect match?
- Werner Turck GmbH & Co. KG
Leiter Qualitätssicherung(m/w/x)
Full-timeWith HomeofficeManagementHalver - BGS Beta-Gamma-Service GmbH & Co. KG
Standortübergreifende Leitung Instandhaltung Medizintechnik(m/w/x)
Full-timeWith HomeofficeSeniorWiehl - Viega
Global Category Manager - Maschinenbeschaffung(m/w/x)
Full-timeWith HomeofficeSeniorAttendorn - Viega
Expert Business Processes Supply Chain(m/w/x)
Full-timeWith HomeofficeExperiencedAttendorn - Chart Industries
EHS Manager(m/w/x)
Full-timeWith HomeofficeExperiencedOlpe