Quality Specialist
Regulatory Affairs Associate
Medical Device Compliance Engineer
Qualitymanagement
R&D
Biotechnik/Medizintechnik
agiles Projektmanagement
English
C2
German
B2
Einsatzorte
Einsatzorte
Deutschland
möglich
Projekte
Projekte
3 years 3 months
2023-04 - now
Quality & Biomedical Engineering
Quality Expert & Biomedical Engineer
Quality Expert & Biomedical Engineer
Quality expert lead of biomaterials for medical devices in collaboration with industrial partners (matrihealth GmbH, EV Group (EVG))
Leading quality management activities according to ISO 13485 and risk management principles following ISO 14971.
Conducted biological evaluation strategies in accordance with DIN EN ISO 10993.
Developed sustainable protein-based and elastin-based biomaterials for medical device applications.
Leading and coordinating CAPA activities, deviation management, and root cause analysis.
Developing strategies for biomaterial inks for scalable manufacturing processes.
Designed antifouling hydrogel coatings reducing protein adsorption and bacterial adhesion by 50?80%.
Applied Design of Experiments (DoE) for formulation optimization and reduced experimental effort by approximately 30%.
Developed elastin- and hyaluronic acid-based biomaterials with improved mechanical stability and hydration towards green materials.
Bioprocess and Analytical Measurement Techniques e.V. (iba)
11 months
2022-02 - 2022-12
Development of implant models
Scientific Project Assistant & Master's Thesis
Scientific Project Assistant & Master's Thesis
Developed hydrogel-based implant models with tunable mechanical properties.
Supported 3D cell culture experiments with cell viability above 90%.
Conducted dynamic mechanical analysis (DMA) and biomaterial characterization.
Supported innovation, IP, and technology transfer activities.
Worked under ISO 13485 and GMP/GLP requirements and documentation for supporting audits.
Supported quality management activities and risk management principles following ISO 14971.
Fraunhofer IMWS
7 months
2021-06 - 2021-12
Hydrogel systems for tissue engineering
Scientific Project Assistant
Scientific Project Assistant
Developed hydrogel systems for tissue engineering.
Produced biocompatible scaffolds using biomaterials for 3D Printing
Conducted material characterization for compliance with biological requirements.
Biocompatibility studies and risk management according to ISO 10993 and ISO 14971.
Martin Luther University Halle-Wittenberg
1 year 2 months
2018-06 - 2019-07
Product Development and Quality Management
QM Engineer
QM Engineer
Supported product development and quality management activities for cardiovascular and external patient monitoring medical devices.
Assisted in implementing quality assurance and risk management processes in accordance with ISO 13485 and ISO 14971 to enhance product traceability and regulatory compliance.
Conducted biological evaluation activities and supported biocompatibility assessments in accordance with DIN EN ISO 10993 for materials with direct and indirect body contact.
Maintained quality documentation and supported regulatory compliance activities using ERP systems.
Participated in preclinical evaluation and documentation activities to support medical device approval and commercialization.
Assisted in audit preparation and quality documentation to ensure compliance with applicable quality and regulatory requirements.
Collaborated with cross-functional teams to support product development, quality assurance and regulatory activities throughout the product lifecycle.
Rheology, DMA, Contact Angle, Zeta Potential, Mechanical Testing, DoE
Manufacturing
3D Bioprinting, Nanoimprint Lithography, Electrospinning
Software
?MS Office, Power BI, SAP, MS Project
Produkte / Standards / Erfahrungen / Methoden
Profile Biomedical Engineer and Quality Specialist with more than 6 years of experience in biomaterials development, medical device R&D, quality management, and regulatory compliance. Experienced in ISO 13485, ISO 14971, ISO 10993, EU MDR, risk management, and biocompatibility evaluation. Skilled in translating laboratory-scale research into industrial applications through collaborations with medical device companies.
Einsatzorte
Einsatzorte
Deutschland
möglich
Projekte
Projekte
3 years 3 months
2023-04 - now
Quality & Biomedical Engineering
Quality Expert & Biomedical Engineer
Quality Expert & Biomedical Engineer
Quality expert lead of biomaterials for medical devices in collaboration with industrial partners (matrihealth GmbH, EV Group (EVG))
Leading quality management activities according to ISO 13485 and risk management principles following ISO 14971.
Conducted biological evaluation strategies in accordance with DIN EN ISO 10993.
Developed sustainable protein-based and elastin-based biomaterials for medical device applications.
Leading and coordinating CAPA activities, deviation management, and root cause analysis.
Developing strategies for biomaterial inks for scalable manufacturing processes.
Designed antifouling hydrogel coatings reducing protein adsorption and bacterial adhesion by 50?80%.
Applied Design of Experiments (DoE) for formulation optimization and reduced experimental effort by approximately 30%.
Developed elastin- and hyaluronic acid-based biomaterials with improved mechanical stability and hydration towards green materials.
Bioprocess and Analytical Measurement Techniques e.V. (iba)
11 months
2022-02 - 2022-12
Development of implant models
Scientific Project Assistant & Master's Thesis
Scientific Project Assistant & Master's Thesis
Developed hydrogel-based implant models with tunable mechanical properties.
Supported 3D cell culture experiments with cell viability above 90%.
Conducted dynamic mechanical analysis (DMA) and biomaterial characterization.
Supported innovation, IP, and technology transfer activities.
Worked under ISO 13485 and GMP/GLP requirements and documentation for supporting audits.
Supported quality management activities and risk management principles following ISO 14971.
Fraunhofer IMWS
7 months
2021-06 - 2021-12
Hydrogel systems for tissue engineering
Scientific Project Assistant
Scientific Project Assistant
Developed hydrogel systems for tissue engineering.
Produced biocompatible scaffolds using biomaterials for 3D Printing
Conducted material characterization for compliance with biological requirements.
Biocompatibility studies and risk management according to ISO 10993 and ISO 14971.
Martin Luther University Halle-Wittenberg
1 year 2 months
2018-06 - 2019-07
Product Development and Quality Management
QM Engineer
QM Engineer
Supported product development and quality management activities for cardiovascular and external patient monitoring medical devices.
Assisted in implementing quality assurance and risk management processes in accordance with ISO 13485 and ISO 14971 to enhance product traceability and regulatory compliance.
Conducted biological evaluation activities and supported biocompatibility assessments in accordance with DIN EN ISO 10993 for materials with direct and indirect body contact.
Maintained quality documentation and supported regulatory compliance activities using ERP systems.
Participated in preclinical evaluation and documentation activities to support medical device approval and commercialization.
Assisted in audit preparation and quality documentation to ensure compliance with applicable quality and regulatory requirements.
Collaborated with cross-functional teams to support product development, quality assurance and regulatory activities throughout the product lifecycle.
Rheology, DMA, Contact Angle, Zeta Potential, Mechanical Testing, DoE
Manufacturing
3D Bioprinting, Nanoimprint Lithography, Electrospinning
Software
?MS Office, Power BI, SAP, MS Project
Produkte / Standards / Erfahrungen / Methoden
Profile Biomedical Engineer and Quality Specialist with more than 6 years of experience in biomaterials development, medical device R&D, quality management, and regulatory compliance. Experienced in ISO 13485, ISO 14971, ISO 10993, EU MDR, risk management, and biocompatibility evaluation. Skilled in translating laboratory-scale research into industrial applications through collaborations with medical device companies.
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