• Consulting on Risk Management according ISO 14971 and ISO 13485
• Competence and skills matrices for all roles in the Quality department
• Draft SOP for all processes in Risk Mgmt., Vigilance Mgmt. and Field Safety Corrective Action processes.
• Consulting on Process Management to optimize organisational efficiency
• Gap analysis towards the recently published Medical Device Regulation and the existing organisation, processes and tools.
• Coaching/Training of new employees according regulations in medical device industry, risk management and related topics

• Remediation of the complete production process
• Project management of all task necessary for the remediation in one production facility of DePuy Synthes
• Risk Management – Definition and implementation of a risk management process including tool support, training of personnel and delivery of the initial risk documentation
• Organisational Development – Definition and implementation of all interfaces to Product Design, Regulatory Affairs, Quality, Operations and the Remediation Program Steering Group
• IT Business Development – Consulting on the appropriate tool support
• Team Leader – Leading the local team of consultants and contractors – including onboarding, daily/weekly task tracking, hierarchal and functional escalation, etc.

Budget: non-disclosed / Team size 4-7 FTE (full time equivalent)

• Organisational Development – Definition and implementation of all interfaces to the involved governmental institutions
• Workshops for the Steering Committee of the Programme on several approaches and models in Organizational Change Management
• Development of a customized approach and a roadmap for the programme
• Training and Coaching of the Change Ambassadors of each governmental institution

Budget: non-disclosed / Team size 5 FTE (full time equivalent)

CASSIDIAN Systems, Business Line of CASSIDIAN, an EADS Company

Responsible for the strategic business of training as a service

Projects in Qatar, UAE, Algeria, Brazil, USA, Romania, Great Britain, France, UK, Germany

• Risk Management – Compliance with national/international laws and standards by definition and implementation of appropriate business processes
• Training Management – Proof of compliance by training management and documentation
• Team Lead: Building a new business unit in EADS with a final size of 10 FTEs

Budget: 10 M€/year / Team size 10 FTE

• Risk management – Compliance with local laws and standard, Identifying risks of non-compliance and management according customer directive
• Training management – Ensuring the knowledge transfer to comply with the customer directive
• Organisational Development – Definition and implementation of processes to comply with of standards and laws in daily operation after the project phase
• Team Lead of 10 FTE in the central business unit and 7 teams in local branches

Budget: 20 M€/year / Team size 35 FTE

• Compliance the EU laws and standards - Adopting the EU regulations to a diagnostic software for Mercedes-Benz Cars
• Risk management – Compliance with all EU regulations defined in the EU5/6 standard
• Project management coaching and training

Budget: 3M€ / Team size 4 FTE

• Process improvement by redesign and implementation after ITIL
• Compliance with national standards and laws to achieve optimal maturity level in ITIL compliance
• Risk management: Identification of financial risks for non-compliance, management of risk (M_o_R according office of government and commerce)
• Project manager for qualification of personal in service? and process management and consultant for financial processes

Budget: undisclosed / 3 FTE