Qualitätsmanagement, Projektmanagement

3/2023 – 6/2023

found in reference description 20
found in reference description 20
CAPA Manager (Interim Solution):
The biggest challenge was that many NC, SCAR and CAPA at the site had to be processed (paper based) and closed after a defined date to meet the FDA, EN ISO 13485:2016, MDR 2017-745 requirements.
Working in an international environment as a quality consultant:
• Document non-conformities and CAPAs and register them in database.
• Maintain CAPA database and provide regular status and trend reporting to management.
• Monitor due dates, regularly remind responsible staff members, and escalate to management if due dates are exceeded.
• Schedule and conduct regular CAPA meetings with staff members.
• Define and plan implementation of CAPA’s and subsequent ECs (effectiveness checks) together with staff members.
• Take part in, lead and independently conduct root cause analysis.
• Create and update SOPs related to the CAPA process.
• Provide training on CAPA system and application of quality tools for root cause analysis to staff members.
• Represent and explain the company’s CAPA system during internal and external audits.
Medical Device Risk Class:
• I-III
Technical environment & methodologies:
• Electrophysiology
• Interventional Cardiology
• Pacing
• OEM Services

Regulatory Affairs, Arbeitsplatzgestaltung, DIN EN ISO 13485, ISO / IEC, Produktionsoptimierung, Prozesscoaching, Prozessoptimierung, Prozessvalidierung, Qualitätsingenieur, Qualitätsmanagement (allg.), Risikoanalyse, Risikomanagement, Validierungsingenieur

1/2022 – 6/2022

The main challenge was that many NCs, SCARs, and CAPAs at the site had to be processed (in SAP) and closed by a defined deadline to comply with FDA, EN ISO 13485:2016, and MDR 2017/745 requirements.
Approach & main achievements
• Clear and well-defined specification of NC projects (SAP-based)
• Creation and closure of NCs (including NCRs, NCs, complaints, CAPAs, SCARs), e.g., cleanroom deviations, power failures, bioburden/sterility assurance level issues, particle contamination, material failures, production defects, etc.
• Development and determination of containment, correction, and corrective actions, as well as material disposition, impact assessments, and preparation of the associated documentation.
• Systematic identification and analysis of the root cause of nonconformities.
• Preparation of weekly progress reports
Technical environment & methodologies:
• Perfusion technology
• Oxygenator

DIN EN ISO 13485, DIN EN ISO 9001, Fertigungsoptimierung, ISO / IEC, Lieferantenmanagement (allg.), Produktionsoptimierung, Prozessoptimierung, Qualitätsingenieur, Qualitätsmanagement (allg.), Regulatory Affairs, SAP S/4HANA, Supply-Chain-Management (SCM), Supply Chain Manager

10/2020 – 12/2022

Consulting and support during PMS activities in accordance with MDR 2017/745, as well as quality support as a Quality Engineer during agile development phases of Class IIa software.:
Working in an international environment as a quality engineering consultant:
• Cyber Security Risk Management,
• Risk Based Complaint Handling acc. to DIN EN ISO 13485 as well as acc. to MDR 2017/745
• CAPA
• Risk Management
• PMS Implementation (PMS Plan, PMS Report, PSUR) acc. to MDR 2017/745
• Creation of PMS and Complaint Trending Reports
Technical environment & methodologies:
• Ophthalmology

Agile Methodologie, Beschwerdemanager, DIN EN ISO 13485, DIN EN ISO 19011, ISO / IEC, Jira, Microsoft Azure, Post-Produktion, Prozessvalidierung, Qualitätsberater, Qualitätsdokumentation, Qualitätsmanager, Regulatory Affairs, Schulung / Coaching (allg.), Scrum, Software Quality, Technische Dokumentation, Test Management, Validierungsingenieur

11/2019 – 5/2020

QUALITY Management – Project Leader
Quality validation engineering and project change management for lubricants

Working in an international environment as a Quality Validation Engineer and Project Manager. The primary challenges included organizing employees from various departments and with different educational backgrounds, managing and evaluating many articles, and meeting strict deadlines. In addition, staff needed to be trained for the respective projects. The work environment was both technically complex and business-oriented
Approach & main achievements
• Execution of validations (IQ, OQ, PQ, compliance analysis, risk-based validation) for manufacturing machines and equipment
• Test Method Validation
• Product change management, including updates to technical file
• Development of the project management plan
• Creation of the site validation master plan
• Project leadership for the lubricant change management project, including updates to all affected technical files.
• Review and creation of inspection processes and inspection sheets
• Development of a procedure for environmental conditions related to chemicals and substances, including their supply chain
• Review and update of the heat-treatment procedure for both external and internal applications
• Preparation of periodic validation reports
• CAPA
Technical environment & methodologies
• Surgery
• Surgical Instruments
• Test Method Validation in the production environment
• IQ, OQ, PQ of CNC machines in the production area
• Statistical methods using Minitab
• Project plan
• Site Master Validation Plan
• Bio Compatibility Test
• Product packaging

DIN EN ISO 13485, DIN EN ISO 19011, DIN EN ISO 9001, ISO / IEC, Lieferantenmanagement (allg.), Prozessoptimierung, Prozessvalidierung, Qualitätsdokumentation, Qualitätsingenieur, Qualitätsmanagement (allg.), Supply-Chain-Management (SCM), Test Management, Validierungsingenieur

11/2018 – 10/2019

Purchasing – Project Leader
Sourcing Quality Engineer and Supplier Quality Engineer
The biggest challenges were integrating employees with different educational backgrounds into the project and implementing a stable purchasing process within the defined deadlines.

Approach & main achievements
• Analysis, improvement and introduction of purchasing process,
• Analysis, improvement and implementation of purchase ordering process,
• Analysis, improvement and introduction of article master data process,
• Analysis, improvement and implementation of HiBE (Hilfs- und Betriebsstoffe) process,
• Document processing of DCR and DCO in Agile,
• Creation and revision of CAPAs, NCs, and Observations in ETQ (as process owner),
• Training employees on the newly introduced purchasing and PP&L procedure.
• Analysis, improvement of the Approved Supplier List in Tuttlingen
• Analysis, improvement of the transport packaging and transport handling procedure
• Project management in the context of CAPA regarding storage conditions for chemicals and substances, including:
- Investigation of the current status (gap-analysis).
- Execution of risk management activities related to HiBE (auxiliary and operating materials)
- Introduction of workplace design in accordance with 5S principles
- Implementation of procedures governing the receipt, handling, and storage of chemicals and substances in designated storage areas.
• Achieved Benefit for the Tuttlingen site:
- A stable HiBE (auxiliary and operating materials) process
- Compliance with storage requirements for chemicals
- Stable ordering process
- Stable suppliers change process.
- Stable article master data process
- Stable order processing process
- No observation/findings after audits
- Stable ASL (Approved Supplier List) Procedure
Technical environment & methodologies
• Surgery
• Surgical Instrument class I-II

Regulatory Affairs, DIN EN ISO 13485, DIN EN ISO 14001, DIN EN ISO 19011, ISO / IEC, Leiter Qualitätsmanagement, Lieferantenmanagement (allg.), Manufacturing Resources Planning, Produktionsoptimierung, Prozessoptimierung, Qualitätsingenieur, Risikoanalyse, Risikomanagement, Supplier Relationship Management (SRM), Supply Chain Manager, Validierungsingenieur

8/2018 – 10/2018

Quality Management – Project Leader
Audit Preparation for the DIN EN ISO 13485:2016 update as well as Medical Device Directive
The biggest challenge for the project was the preparation for ISO 13485: 2016
certification audit had to be completed within eight weeks.
Approach & main achievements
• Gap-Analysis of the Risk Management Procedure as well as Risk Management Files (particularly pFMEA)
• Gap analysis of the Process Validation Procedure and the corresponding validation files (TMV, IQ, OQ, PQ, packaging, injection molding, sterilization procedures, CSV)
• Creation a Quality Improvement Plan
• Recommendations
Technical environment & methodologies
• Urology
• Catheter
• Product Packaging DIN EN ISO 11607

Prozessoptimierung, Qualitätsingenieur, Validierungsingenieur, Prozessvalidierung, Risikomanagement, DIN EN ISO 13485, DIN EN ISO 19011, DIN EN ISO 9001, Vorbereitung auf QM-Zertifizierung (ISO)

3/2018 – 8/2018

Quality Management
Quality Engineering Consultant for Manufacturing Transfer (Active Medical Device)
The primary challenge of the project was to prepare the production transfer from the Berlin facility in a way that ensured uninterrupted and compliant manufacturing of active medical devices at the Freiburg site.
Approach & main achievements
• Supported the manufacturing transfer by performing a wide range of quality-related activities
• Created and monitored engineering and QMS change requests
• Transferred NCs/CAPAs to the receiving site and led the completion of all NC/CAPA activities
• Supported inspection planning and initial sample evaluations (main focus)
• Contributed to the implementation of manufacturing processes for transferred products
• Served as a subject matter expert for process risk analyses and FMEAs
• Monitored critical process validations (e.g., welding, gluing)
• Supported the development and monitoring of equipment and process validations/qualifications.
Technical environment & methodologies
• Image guided Therapies

Supply-Chain-Management (SCM), Regulatory Affairs, DIN EN ISO 13485, DIN EN ISO 19011, Fehlermöglichkeits- und -einflussanalyse (FMEA), Produktionsentwicklung, Produktionsoptimierung, Produktionsplanung und -steuerung (PPS), Projektmanagement, Prozessoptimierung, Prozessvalidierung, Risikomanagement, Schulung / Coaching (allg.), Test Management

4/2017 – 2/2018

Quality Management - Leadership
Head of Post Market Surveillance & Operational Quality
The main challenges in this role were related to gaining practical experience with the newly introduced EU MDR requirements and integrating these regulatory changes into existing processes. The complexity and diversity of the project landscape required significant stakeholder engagement and persuasion to ensure cross-functional alignment and regulatory compliance.
Approach & main achievements
• Introduction of the Post-Market Surveillance (PMS) process in accordance with the Medical Device Regulation (MDR 2017/745)
• Development of PMS documentation, including:
– Post-Market Surveillance Plan (MDR Article 84)
– Post-Market Surveillance Report (MDR Article 85)
– Periodic Safety Update Report (PSUR) (MDR Article 86)
• Execution of vigilance activities and Medical Device Reporting in accordance with MDR Articles 87–92
• Enhancement of quality system processes, including:
– Complaint handling
– Product CAPA processes
– Product change management processes
• Risk assessment and risk management in accordance with ISO 14971:2012
• Creation of Clinical Evaluation Reports (CERs) for Class II–III active medical electrical devices in accordance with MEDDEV 2.7/1 Rev. 4 (seven CERs completed)
• Preparation for regulatory inspections (Swissmedic, FDA, MDSAP, TÜV SÜD)
• Reporting to Global Product Management
• Regulatory Affairs responsibilities (as Regulatory Compliance Manager):
– Completion of Technical Documentation for the EU (DoC)
– Preparation of submissions for the US (510(k))
– Support for registrations in the Asian market (China, CFDA/NMPA
Technical environment & methodologies:
• Active Medical Devices
• Blood Pressure Analysis
• Electrocardiography
• Lung Function Testing
• HL7 Applications
• Spirometry
• Ergo Spirometry (Cardiopulmonary Exercise Testing)
• Bodyplethismogrphy

Klinische Arbeiten, GXP, Kardiologie, FMEA (Failure Mode and Effects Analysis), Prozessoptimierung, Risikoanalyse, Post-Produktion, Leiter Qualitätsmanagement, Regulatory Affairs Manager, Schulung / Coaching (allg.), Prozessmanagement, Risikomanagement, DIN EN ISO 13485

10/2016 – 4/2017

Senior Quality Engineer:
The biggest challenge was that a large number of NCs and CAPAs at the site had to be processed and closed by a defined deadline in order to meet FDA requirements.
Approach & main achievements
• Clear / concrete definition of NC-Projects
• Creation and closure of NCs (including NCR, NC, Complaints, CAPAs) in area such as clean room, power failures, bioburden sterility assurance level, particle level, Material failure, production failure etc.
• Development and determination of containment, correction and corrective action corrective action, including material disposition, impact assessments, and creation of all related documentation.
• Systematic determination of root causes for non-conformities.
• Preparation of weekly status and progress reports

Technical environment & methodologies:
• Perfusion technology
• Oxygenator

Lieferantenmanagement (allg.), Supply-Chain-Management (SCM), ISO / IEC, Arbeitsplatzgestaltung, Design (allg.), DIN EN ISO 13485, DIN EN ISO 14001, DIN EN ISO 19011, Produktionsoptimierung, Projektmanagement, Prozessoptimierung, Prozessvalidierung, Qualitätsingenieur, Qualitätsmanagement (allg.), Regulatory Affairs, Risikoanalyse, Risikomanagement, Spritzgießer Kunststofftechnik, Validierungsingenieur

9/2015 – 9/2016

Quality Management – Leadership:
CAPA Process and CAPA Coordination
The biggest challenge was that numerous CAPAs at the site had to be processed and closed by a defined deadline in order to meet regulatory requirements. Additionally, employees received regular training during the completion of the CAPAs
Approach & main achievements
• Improvement of CAPA Process
• Development and successful implementation of a new CAPA SOP
• CAPA Coordination (Amount of CAPA: 136, 80% were completed)
Technical environment & methodologies:
• In Vitro Diagnostic
• Laboratory Systems for In Vitro Diagnostic

ISO / IEC, Prozessoptimierung, Qualitätsingenieur, Validierungsingenieur, Prozessvalidierung, Risikoanalyse, Regulatory Affairs, Risikomanagement, DIN EN ISO 13485, Qualitätsmanagement (allg.)

1/2015 – 8/2015

Quality Management – Leadership:
DHF Remediation Engineering Consultant
Organizing ~2,000 articles into families and remediating legacy issues.
Approach & main achievements
• Technical writing and technical justifications
• DHF remediation according to approved plan
• Development of protocols and procedures
• Understanding system/functional testing of medical devices
• Analysis and improvement of Risk Management Process; release of RM files for implants and instruments
• Identification of use-related hazards/human factors based on surgical techniques
• Risk management according to ISO 14971
• Introduction of complaint summary reports and risk management reports
Technical environment & methodologies:
• Passive Medical Devices Class I-III
• Surgery
• Surgical Technics
• Surgical Instruments and Implants

Regulatory Affairs Manager, Design-Ingenieur, DIN EN ISO 13485, DIN EN ISO 19011, DIN EN ISO 9001, ISO / IEC, Produktionsoptimierung, Prozessoptimierung, Prozessvalidierung, Qualitätsingenieur, Qualitätsmanagement (allg.), Regulatory Affairs, Risikomanagement, Validierungsingenieur, Vorbereitung auf QM-Zertifizierung (ISO)

10/2014 – 12/2014

Quality Management
Senior Quality Engineering Consultant/Production Risk Analysis Consultant
The biggest challenges in the project were to consolidate many articles into article families and to remediate the associated legacy issues.
Approach & main achievements
• Creation of uniform and traceable production risk management analyses for all implants and instruments (in collaboration with subject matter experts) in accordance with ISO 14971
• Support for manufacturing sites in implementing the production risk analysis process
• Development of standardized FMEA modules and templates
Technical environment & methodologies:
• Passive Medical Devices Class I-III
• Surgery
• Surgical Instruments and Implants for the specific therapies

DIN EN ISO 13485, FMEA (Failure Mode and Effects Analysis), Prozessoptimierung, Prozessvalidierung, Qualitätsingenieur, Regulatory Affairs Manager, Risiko-Manager

11/2013 – 6/2014

Manufacturing Engineering / Validation
GRQP Manufacturing Engineering Consultant/Validation Consultant
The biggest challenges in the project were consolidating a large number of articles into article families and remediating the associated legacy issues.
Approach & main achievements
• Compiled traceable process validation documentation for medical devices with respect to cleanliness and biocompatibility.
• Supported manufacturing sites in implementing biocompatibility and cleanliness processes.
• Prepared complete and traceable electronic documentation of cleanliness validation and biological safety evaluation (as part of the Device Master Record, DMR).
• Reviewed and integrated manufacturing process validation and test data into documentation management systems.
• Assessed the cleanliness and biocompatibility status of existing manufacturing processes (in collaboration with subject matter experts).
• Responsible for conducting cleanliness validation activities within manufacturing.
• Coordinated external cleanliness testing in collaboration with internal units (e.g., cytotoxicity, bioburden, Fourier Transform Infrared Spectroscopy (FTIR), Total Organic Carbon (TOC)).
• Documented process monitoring activities related to cleanliness
• Acted as an interface between various functions (manufacturing, process validation, materials testing, risk management)
Technical environment & methodologies:
• Passive Medical Devices class I-III
• Surgery
• Surgical Instruments and Implants for the specific therapies

Datenanalyse, DIN EN ISO 13485, Fehlermöglichkeits- und -einflussanalyse (FMEA), Lieferantenmanagement (allg.), Medizintechnik, Prozessoptimierung, Prozessvalidierung, Qualitätsingenieur, Qualitätsmanagement (allg.), Regulatory Affairs, Regulatory Affairs Manager, Risikoanalyse, Risikomanagement, Technische Beratung, Validierungsingenieur

5/2013 – 10/2013

Quality Engineer / FMEA Moderator

Approach & main achievements
• Moderation of FMEAs during the product development and design transfer phases, as well as updating existing FMEAs
• Ensuring adherence to the defined methodology and compliance with all formal FMEA requirements
• Maintaining consistency between Design FMEA (dFMEA) and Process FMEA (pFMEA)
• Supporting design experts, development engineers, and manufacturing engineers in the creation of control plans and reaction plans
• Developing standardized FMEA modules
• Monitoring the progress and timely completion of FMEA projects
• Documenting, reviewing, approving, and archiving FMEA records
Technical environment & methodologies:
• Automotive
• Manufacturing of the Multimedia Device for the cars
• Injection Molding of Plastic

DIN EN ISO 9001, FMEA (Failure Mode and Effects Analysis), IATF 16949, Moderator, Prozessoptimierung, Qualitätsingenieur, Risikomanagement, Statistische Prozessregelung (SPC)

9/2009 – 5/2013

Leitung Qualitätsmanagement:

- Verantwortlich, dass die für das Qualitätsmanagementsystem erforderlichen Prozesse eingeführt, verwirklicht und aufrecht erhalten werden,
-Der obersten Leitung über die Leistung des Qualitätsmanagementsystems und jegliche Notwendigkeit für Verbesserungen zu berichten
-Die Förderung des Bewusstseins im Unternehmen für die gesetzliche Anforderungen und Kundenanforderungen
- Interne und externe Audits planen, vorbereiten und durchführen
- Betreuung von OEM-Partnern, Vertriebspartnern, Lieferanten, Zertifizierungs- und Prüfinstituten in Qualitätsmanagement Angelegenheiten
- Durchführung von Produkt- und Prozessfreigaben
- Erstellung von Managementbewertungen

Leitung Qualitätsplanung:

- Optimierung, Koordination, Durchführung und Betreuung des Risikomanagementprozesses (FMEA nach DIN 14971)
- Förderung des Qualitätsbewusstseins der Mitarbeiter durch schulungen in Bezug auf Risikomanagement- und Validierungsprozesse nach Medizinprodukte Gesetz, DIN EN ISO 13485, ISO 9001 und harmonisierte Normen,
- Einführung, Optimierung, Koordination und Durchführung von Verifizierungs- und Validierungsverfahren und Prozessen, nach harmonisierten Normen
- Einführung, Optimierung, Koordination und Durchführung von Kontrollplänen, Produktionslenkungsplänen, Prüfplänen, Änderungsmanagement, Arbeitsanweisungen sowie Herstellanweisungen
- Planung und Überwachung von Produkt- und Prozeßfreigaben

Leitung Zulassungsmanagement:

- Erhaltung und regulatorische Betreuung von Gerätezulassungen für in- und Ausland
- Koordination und Freigabe technischer Dokumentation
- Durchführung aller notwendigen Aktivitäten zur Erlangung, Aufrechterhaltung und Pflege von Internationalen Zulassungen und Zertifizierungen für die GANSHORN Medizinprodukte
- Einführung und Überwachung von anzuwendenden Normen und Richtlinien
- Förderung des Qualitätsbewußtseins der Mitarbeiter durch Schulungen nach dem Medizinprodukte Gesetz, sowie nach nationalen und internationalen gesetzlichen Vorgaben für Medizinprodukte
- Klinische Bewertung von aktiven Medizinprodukten Klasse IIa

Risikomanagement, Arbeitsablaufplanung, Arbeitsplatzgestaltung, Audits, DIN EN ISO 13485, DIN EN ISO 19011, DIN EN ISO 9001, ISO / IEC, Management-Schulung, Management (allg.), Medizintechnik, Post-Produktion, Produktionsentwicklung, Produktionsoptimierung, Produktionsplan, Produktionsplanung und -steuerung (PPS), Prozessoptimierung, Prozessvalidierung, Qualitätsdokumentation, Qualitätshandbuch, Qualitätslenkung, Qualitätsmanagement (allg.), Qualitätsmanager, Regulatory Affairs, Regulatory Affairs Manager, Schulung / Coaching (allg.), Schulungskonzepte, Software Quality, Softwaredokumentation, Supply-Chain-Management (SCM), Technische Projektleitung / Teamleitung, Vorbereitung auf QM-Zertifizierung (ISO), Zeichnungs- / Stücklistenorganisation

4/2009 – 8/2009

Training
Managementgrundlagen, BWL, Marketing, Kommunikation,
Qualitätsmanagement mit Prüfung zum QM,
Projektmanagement I,
Methodenkompetenz Projektmanagement II

7/2008 – 4/2009

Six Sigma, Six Sigma Lean, DFSS im Hause Volke:

Prüfung der Notwendigkeit der Implementierung von Six Sigma und Lean Management-Strategien,
Recherche über Kosten / Nutzen von Six Sigma und Lean,
Qualitätsinstrumente und Methoden von Six Sigma,
Projektauswahl und Implementierung,
Wahl der geeigneten Vorgehensweise,
Nachhaltige Sicherstellung von Ergebnissen,
Durchführung von Six Sigma Yellow Belt-Schulungen

Regulatory Affairs, Automotive Electronics, Beschwerdemanager, CAD (computer-aided design), Change Management, DIN EN ISO 19011, DIN EN ISO 9001, Fehlermöglichkeits- und -einflussanalyse (FMEA), ISO / IEC, ISO/TS 16949, Just-in-time-Produktion (JIT), Lean Prozesse, Post-Produktion, Produktionsoptimierung, Produktionstechnik (allg.), Prozessoptimierung, Prozessvalidierung, Qualitätsingenieur, SAP R/3, Schulung / Coaching (allg.), Supply-Chain-Management (SCM), Teamleiter, Test Management, Versorgungstechnik (allg.)

1/2007 – 6/2008

Erfassen, dokumentieren und verfolgen qualitätsrelevanter Problempunkte und Maßnahmen,
Verfolgen von Risikoschwerpunkten und Top-Themen,
Durchführung von Gewährleistung und Kulanzkosten-Analysen,
Schaffung von Transparenz in den Qualitätsständen, als Basis für eine plausible Zielverfolgung,
Erstellen von Qualitätsstatistiken gemäß Qualitäts- und Synchronplan,
Erstellung von Prognosen,
Prozessanalyse und Prozessoptimierung

1/2007 – 7/2007

Anlaufsteuerer im Fahrzeugprojekt mit Auslandsaufenthalt (England / Goodwood)

Initiierung, Gestaltung und Verfolgung von Maßnahmen zur Qualitätszielerreichung
Erreichung der Vereinbarten Qualitätskennzahlen durch Qualitätszielführung
Qualitätsberichtswesen im Modul,
Bereitstellung des Q-Reporting inklusive Chancen und Risiken für den Modulumfang
Eskalation (mit bewerteten Lösungsalternativen) zum Modulleiter

1/2006 – 6/2008

Entwicklung Antrieb V8 und V12 – Motoren als Änderungsmanager:

Optimierung und Verbesserung des Änderungsmanagementprozess im V-Motorenprojekt,
Durchführung von Schwachstellenanalysen und Einleiten von Gegenmaßnahmen,
Herbeiführen von Entscheidungen bei Problemfällen unter Berücksichtigung der Eskalationswege
Vorbereiten, nachbereiten und moderieren von Änderungsrunden,
Schaffen von Transparenz durch regelmäßiges Änderungsmanagementreporting,
Überprüfung der Mengengerüste Kostenreduktion durch Prozessoptimierung

7/2003 – 12/2005

Änderungs- und Qualitätsbeauftragter im Wasserstofffahrzeugprojekt:

Implementierung eines Änderungsmanagementtools im Projekt,
Organisation, Moderation, Vorbereitung und Nachbereitung von Genehmigungsrunden / Qualitätsrunden,
Gewährleistung von Transparenz im Änderungsmanagement / Qualitätsmanagement
Implementierung des Änderungsmanagements im Projekt,
Schnittstellenbildung zu allen relevanten Fachstellen,
Erarbeitung von Fachkonzepten,
Darstellung der Problemlandschaft,
Vertretung der Projektinteressen in Gremien,
Absicherung der Prozesssicherheit,
Prozessabgleich mit Lieferanten und Entwicklungspartnern

5/2002 – 6/2003

Problemmanagement, Prozessoptimierung, Transparenz und Kostenreduktion bei Änderungen mit dem Focus Gesamtfahrzeug im Projekt.

2/2001 – 4/2002

Durchführung und Auswertung der Festigkeitsversuche an Antriebsbauteilen (statische- und dynamische Belastung) Untersuchung von Schraubverbindungen Dokumentation der Versuchsergebnisse Konstruktion von Aufnahmevorrichtungen für die zu prüfenden Bauteile mit CAD (Catia V5, Solide Edge) Erstellung von Angebotsanfragen für die Vorrichtungen