Freelancer Medical Device / Pharmaceutical Industry

1/2013 – 6/2015

In Charge for:
- Lead of external Audits and Audit-preparation
- Internal Auditor on site- Global Subject Matter Expert for Validation and Qualification
- Global Trainer for Qualification and Validation processes
- Responsible for the release of specifications for incoming inspections as well as the FAI (First Article
Inspection)
- Risk Management (FMEA Moderator for Process and Design FMEAs)
- QA representative within development projects of new products
- Complaint handling process
Projects:
- Successful GAP Analyses of the existing global QM System regarding ISO 13485 andCFR Part 820
compliance
- Development and successful implementation of a slim risk based approach for globalQualification and
Validation Process CSV and MSA (Measurement System Analyses) in accordance of ISO13485 and
CFR Part 820 requirements
- Several Qualification, Validation and CAPA Projects

Management (allg.), Risikomanagement, Fehlermöglichkeits- und -einflussanalyse (FMEA), Auditor

3/2012 – 12/2012

In Charge for:
- Lead of Management Review and the Corrective Action Board on site
- Preparation and conduction of global Management Review
- Responsible for global stop shipment and recall process as well as data preparation forstop shipment
and recall Decisions
- Responsible for the training system and Audit processes on site
- Lead of Auditpreparation for AQR, TUV, ANVISTA and FDA Audits
- Consulting and Reporting of Senior Management regarding all internal and externalCompliance
Questions
Projects:
- Development of Processes and Tools for Quality Data Analyses- Defining Quality Goals

Reporting, Management (allg.), Auditor

2/2011 – 2/2012

In Charge for:
- Subject Matter Expert for the CAPA and Complaint handling processes
- Abbott CAPA Certified Trainer (for Initiator, Investigator, Resolution Planner andApprover
function)
- CAPA Mentor on site
- Lead of Nonconforming Product Meeting
- Writing Process FMEAs
Projects:
- Successful implementation of the Divisional Nonconforming Material processes as wellas the global
reporting process for the CAPA System inclusive development of CAPA and Scrap
trendingprocesses to calculate Nonconforming Risk Data

Reporting, FMEA (Failure Mode and Effects Analysis), Schulung / Training (IT), Risikomanagement