Werner Turck GmbH & Co. KG
Leiter Qualitätssicherung(m/w/x)
Full-timeWith HomeofficeManagement
Halver
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Operational delivery for medical schemes, overseeing MDR/IVDR conformity assessment at global testing, inspection, certification leader. Proven leadership in regulated environments with deep EU MDR/IVDR knowledge required. Flexible schedule, hybrid work, SGS university.
Requirements
- Strong understanding of EU MDR, EU IVDR, UKCA, MDSAP, ISO13485, MDD
- Proven solid leadership in managing cross-functional teams in regulated environments
- Knowledge of conformity assessment procedures and QMS requirements
- Excellent interpersonal and stakeholder management skills
- Strong organizational and change management capabilities
- Strong commercial understanding and appreciation of TIC industry
- Experience in resource planning
- Qualification as Lead Auditor or Product Assessor under EU MDR/EU IVDR
- Qualification as Final Reviewer and Decision Maker under MDR or IVDR
- Experience in a Notified Body or equivalent regulatory organization
- Minimum 10 years in medical device or IVD industry, including design, manufacturing, auditing, or technical documentation assessment experience
- At least 5 years senior leadership in a Notified Body managing technical employees
- Minimum 2 years in revenue-focused leadership roles, including P&L accountability, budget management, financial reporting
- Demonstrated success in P&L role
- Demonstrated success in leading high-performing teams, driving operational efficiency, delivering positive organizational impact
- Fluency in English and local language
- Experience gained within SGS Group (advantageous)
- University degree in medicine, engineering, life sciences, or related field
Tasks
- Lead and coordinate operational delivery for medical schemes.
- Oversee MDR and IVDR conformity assessment activities.
- Ensure effective performance of clinical, audit, technical, and product assessment functions.
- Drive operational excellence, regulatory compliance, and strategic resource management.
- Oversee all technical teams.
- Manage technical team performance.
- Support development of processes, systems, and personnel.
- Lead and manage global technical functions for medical schemes.
- Ensure compliance with ISO 13485, MDSAP, UKCA, and EU MDR/IVDR requirements.
- Ensure efficient allocation and utilization of technical resources.
- Manage technical certification activities.
- Monitor technical KPIs.
- Implement process improvements for certification.
- Lead training and competence management strategies.
- Maintain regulatory and technical expertise.
- Support recruitment, onboarding, and qualification of personnel.
- Drive continuous improvement for technical workflows.
- Improve IT systems supporting assessment.
- Enhance quality management processes.
- Interface with regulatory authorities and accreditation bodies.
- Interface with internal stakeholders.
- Maintain SGS reputation, designations, and accreditations.
- Ensure SGS compliance.
- Monitor and respond to regulatory changes.
- Monitor and respond to industry trends.
- Monitor and respond to accreditation requirements.
- Adapt technical operations proactively.
- Manage and promote impartiality policies.
- Manage and promote conflict of interest policies.
- Ensure independent conformity assessment decisions.
- Ensure compliance with SGS integrity policies.
- Ensure compliance with health and safety standards.
- Ensure confidentiality across technical operations.
- Foster a culture of client focus and integrity.
- Promote continuous development within teams.
- Collaborate with Commercial & Delivery teams.
- Harmonize contract, planning, and assessment handovers.
- Align capacity with demand.
- Support timely service delivery.
- Provide strategic input for designation maintenance.
- Provide strategic input for regulatory engagement.
- Coordinate technical evidence and metrics.
- Coordinate remediation plans.
- Provide technical input for business development and bids.
- Support budget and KPI visibility for operations.
- Contribute to overall performance management.
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- EU MDR
- EU IVDR
- UKCA
- MDSAP
- ISO13485
- MDD
- QMS
Benefits
Flexible Working
- Flexible schedule
- Hybrid model
Learning & Development
- SGS university
- Continuous learning options
- Personal development
Informal Culture
- Multinational environment
Startup Environment
- Supportive and inclusive work environment
Career Advancement
- Professional growth
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.
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Operational delivery for medical schemes, overseeing MDR/IVDR conformity assessment at global testing, inspection, certification leader. Proven leadership in regulated environments with deep EU MDR/IVDR knowledge required. Flexible schedule, hybrid work, SGS university.
Requirements
- Strong understanding of EU MDR, EU IVDR, UKCA, MDSAP, ISO13485, MDD
- Proven solid leadership in managing cross-functional teams in regulated environments
- Knowledge of conformity assessment procedures and QMS requirements
- Excellent interpersonal and stakeholder management skills
- Strong organizational and change management capabilities
- Strong commercial understanding and appreciation of TIC industry
- Experience in resource planning
- Qualification as Lead Auditor or Product Assessor under EU MDR/EU IVDR
- Qualification as Final Reviewer and Decision Maker under MDR or IVDR
- Experience in a Notified Body or equivalent regulatory organization
- Minimum 10 years in medical device or IVD industry, including design, manufacturing, auditing, or technical documentation assessment experience
- At least 5 years senior leadership in a Notified Body managing technical employees
- Minimum 2 years in revenue-focused leadership roles, including P&L accountability, budget management, financial reporting
- Demonstrated success in P&L role
- Demonstrated success in leading high-performing teams, driving operational efficiency, delivering positive organizational impact
- Fluency in English and local language
- Experience gained within SGS Group (advantageous)
- University degree in medicine, engineering, life sciences, or related field
Tasks
- Lead and coordinate operational delivery for medical schemes.
- Oversee MDR and IVDR conformity assessment activities.
- Ensure effective performance of clinical, audit, technical, and product assessment functions.
- Drive operational excellence, regulatory compliance, and strategic resource management.
- Oversee all technical teams.
- Manage technical team performance.
- Support development of processes, systems, and personnel.
- Lead and manage global technical functions for medical schemes.
- Ensure compliance with ISO 13485, MDSAP, UKCA, and EU MDR/IVDR requirements.
- Ensure efficient allocation and utilization of technical resources.
- Manage technical certification activities.
- Monitor technical KPIs.
- Implement process improvements for certification.
- Lead training and competence management strategies.
- Maintain regulatory and technical expertise.
- Support recruitment, onboarding, and qualification of personnel.
- Drive continuous improvement for technical workflows.
- Improve IT systems supporting assessment.
- Enhance quality management processes.
- Interface with regulatory authorities and accreditation bodies.
- Interface with internal stakeholders.
- Maintain SGS reputation, designations, and accreditations.
- Ensure SGS compliance.
- Monitor and respond to regulatory changes.
- Monitor and respond to industry trends.
- Monitor and respond to accreditation requirements.
- Adapt technical operations proactively.
- Manage and promote impartiality policies.
- Manage and promote conflict of interest policies.
- Ensure independent conformity assessment decisions.
- Ensure compliance with SGS integrity policies.
- Ensure compliance with health and safety standards.
- Ensure confidentiality across technical operations.
- Foster a culture of client focus and integrity.
- Promote continuous development within teams.
- Collaborate with Commercial & Delivery teams.
- Harmonize contract, planning, and assessment handovers.
- Align capacity with demand.
- Support timely service delivery.
- Provide strategic input for designation maintenance.
- Provide strategic input for regulatory engagement.
- Coordinate technical evidence and metrics.
- Coordinate remediation plans.
- Provide technical input for business development and bids.
- Support budget and KPI visibility for operations.
- Contribute to overall performance management.
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- EU MDR
- EU IVDR
- UKCA
- MDSAP
- ISO13485
- MDD
- QMS
Benefits
Flexible Working
- Flexible schedule
- Hybrid model
Learning & Development
- SGS university
- Continuous learning options
- Personal development
Informal Culture
- Multinational environment
Startup Environment
- Supportive and inclusive work environment
Career Advancement
- Professional growth
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
Management
Description
Das Unternehmen ist das weltweit führende Unternehmen in den Bereichen Prüfen, Inspizieren und Zertifizieren.
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