Lamm HR GmbH
Leiter Qualitätsmanagement Medizingeräteentwicklung(m/w/x)
Full-timeTemporary contractWith HomeofficeSenior
Frankfurt am Main
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FRFresenius Medical Care D. GmbH
Head of Design Quality Assurance(m/w/x)
Bad Homburg vor der Höhe
Full-timeWith Home OfficeSenior
Nejo AI Summary
Global leadership and coordination of Design Quality Assurance for active, nonactive, and digital medical devices. 5+ years in medical device R&D/QA/RA with advanced medical device regulations knowledge required. Strategic quality assurance development and global team leadership.
Requirements
- Completed bachelor’s or master’s degree in engineering, medical technology, or natural sciences
- Minimum 5 years experience in R&D, regulatory affairs, or quality management for medical devices or pharmaceuticals
- Advanced knowledge of medical device regulations (FDA 21 CFR 820, NMPA, EU MDR 745/2017, MDSAP)
- Advanced knowledge of quality and risk management standards (ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR §820.250)
- Knowledge of internal/external processes, structures, and corporate quality management
- Solid knowledge of CAPA methodology
- Knowledge of Medical Device field and application
- High engagement for targets and objectives
- Proactive and solution-oriented approach
- Cross-functional teamwork ability
- Good professional relationships and communication with international colleagues/superiors
- Fluent written and spoken English
- Fluent written and spoken German
Tasks
- Provide global disciplinary and functional leadership to the DQA team
- Define and implement the DQA strategy and operating model
- Develop the DQA team, including resource and succession planning
- Build DQA team capabilities and map competencies
- Ensure effective task distribution and resource alignment
- Ensure global team performance delivery
- Promote a culture of continuous improvement and operational excellence
- Represent DQA in global and local leadership meetings
- Represent DQA in quality committees and governance bodies
- Collaborate on Design Quality strategy and process evolution
- Ensure functional alignment within Design Quality
- Lead the global design quality assurance strategy
- Harmonize design quality processes globally
- Contribute to regulatory readiness and innovation enablement
- Enhance Business Unit design quality maturity
- Coordinate and implement design control activities for all projects
- Oversee compliance with regulations and internal SOPs
- Establish and maintain design quality processes and tools
- Manage design reviews, phase gates, and documentation systems
- Monitor and ensure global design assurance consistency
- Ensure high performance of design assurance execution
- Ensure clear ownership of deliverables (quality, time, cost)
- Align with manufacturing and supplier quality teams
- Ensure smooth design transfer and product realization
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- FDA 21 CFR 820
- NMPA regulation
- EU MDR 745/2017
- MDSAP
- ISO13485
- ISO14971
- ICH Q10
- EU GMP
- FDA 21 CDR §820.250
- CAPA methodology
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Medical Care D. GmbH 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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FRFresenius Medical Care D. GmbH
Head of Design Quality Assurance(m/w/x)
Bad Homburg vor der Höhe
Full-timeWith Home OfficeSenior
Nejo AI Summary
Global leadership and coordination of Design Quality Assurance for active, nonactive, and digital medical devices. 5+ years in medical device R&D/QA/RA with advanced medical device regulations knowledge required. Strategic quality assurance development and global team leadership.
Requirements
- Completed bachelor’s or master’s degree in engineering, medical technology, or natural sciences
- Minimum 5 years experience in R&D, regulatory affairs, or quality management for medical devices or pharmaceuticals
- Advanced knowledge of medical device regulations (FDA 21 CFR 820, NMPA, EU MDR 745/2017, MDSAP)
- Advanced knowledge of quality and risk management standards (ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR §820.250)
- Knowledge of internal/external processes, structures, and corporate quality management
- Solid knowledge of CAPA methodology
- Knowledge of Medical Device field and application
- High engagement for targets and objectives
- Proactive and solution-oriented approach
- Cross-functional teamwork ability
- Good professional relationships and communication with international colleagues/superiors
- Fluent written and spoken English
- Fluent written and spoken German
Tasks
- Provide global disciplinary and functional leadership to the DQA team
- Define and implement the DQA strategy and operating model
- Develop the DQA team, including resource and succession planning
- Build DQA team capabilities and map competencies
- Ensure effective task distribution and resource alignment
- Ensure global team performance delivery
- Promote a culture of continuous improvement and operational excellence
- Represent DQA in global and local leadership meetings
- Represent DQA in quality committees and governance bodies
- Collaborate on Design Quality strategy and process evolution
- Ensure functional alignment within Design Quality
- Lead the global design quality assurance strategy
- Harmonize design quality processes globally
- Contribute to regulatory readiness and innovation enablement
- Enhance Business Unit design quality maturity
- Coordinate and implement design control activities for all projects
- Oversee compliance with regulations and internal SOPs
- Establish and maintain design quality processes and tools
- Manage design reviews, phase gates, and documentation systems
- Monitor and ensure global design assurance consistency
- Ensure high performance of design assurance execution
- Ensure clear ownership of deliverables (quality, time, cost)
- Align with manufacturing and supplier quality teams
- Ensure smooth design transfer and product realization
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- FDA 21 CFR 820
- NMPA regulation
- EU MDR 745/2017
- MDSAP
- ISO13485
- ISO14971
- ICH Q10
- EU GMP
- FDA 21 CDR §820.250
- CAPA methodology
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Medical Care D. GmbH 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
Fresenius Medical Care D. GmbH
Industry
Healthcare
Description
The company is dedicated to improving the lives of patients with chronic kidney disease through innovative, high-quality products and treatments.
Not a perfect match?
- Lamm HR GmbH
Leiter Qualitätsmanagement Medizingeräteentwicklung(m/w/x)
Full-timeTemporary contractWith HomeofficeSeniorFrankfurt am Main - Fresenius Medical Care D. GmbH
Product Center Manager Active Medical Devices & Digital Products(m/w/x)
Full-timeWith HomeofficeExperiencedBad Homburg vor der Höhe - Fresenius Medical Care D. GmbH
Risk Manager Active Medical Devices and Digital Products(m/w/x)
Full-timeWith HomeofficeSeniorBad Homburg vor der Höhe - CAPGEMINI SERVICE SAS
Verification & Validation Med Tech(m/w/x)
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Lead Validation & Test Manager(m/w/x)
Full-timeRemoteSeniorFrankfurt am Main