Project Leader, Quality Manager

3/2013 – 8/2015

Management Consultant, Altran
March 2013 – Present (2 years 5 months)Malmo, Sweden
Roles:
• Quality Manager
• Project Leader
• Life Science Expert

Tasks:
• Leading Product Development
• Assure design control (FDA/CE), inspection readiness
• Forming teams and coordinating activities throughout all cross function
• Building up management systems with focus on ISO 9001, 13485, 14001, OSH
• Commissioning, FAT/SAT, validation, ramp-up and handover to production
• Close communication with federal agencies, business development team and customers regarding regulatory and quality requirements
• Gap analysis, secure alignment to ISO standards, GMP and regulatory requirements (MDD 93/42-EEC, FDA 21 CFR 820)

Clients:
• Vigmed AB. A listed Swedish medtec company started with the idea, to eliminating needlestick injuries
• European Spallation Source (ESS). A multi-disciplinary research centre based on the world’s most powerful neutron source and one of the largest science and technology infrastructure projects being built today
• McNeil. Part of the fortune 500 Johnson & Johnson multinational medical devices, pharmaceutical and consumer packaged goods manufacturer
• GN Resound. One of the World’s largest providers of hearing aids and diagnostic audiological instrumentation

Hardware Entwicklung, Projektleitung / Teamleitung (IT), SAP Beratung (allg.), Telekommunikation / Netzwerke (allg.), IT-Beratung (allg.), Management (allg.), Business Development, Qualitätsmanagement (allg.), DIN EN ISO 9001, Kommunikation (allg.), Public Relations, Design (allg.), Adobe InDesign, Forschung & Entwicklung (allg.), Pharmazie

1/2008 – 2/2013

Project Lead and Head of the Core Team for Medical Device development projects for complex intensive care machines.

Roles contained organizing, planning, coordinating, and managing multiple work-streams during all phases from conception via development, production implementation to global market introduction. Securing regulatory conform project execution incl. risk, standard compliance and documentation for 510(k)/ CE mark with responsibility for budget, cross-functional teams, deliverables, business cases, and top management communication. 60601 3rd edition

Projektleitung / Teamleitung

1/2007 – 11/2008

Managing and coordinating Medical Device development projects:

Managed several projects for disposables, and machines for intensive and chronic care. Roles contained responsibility for outcome, KPIs definition, design control, DMR, V&V and interaction with test houses.

Prozessmanagement