Period |
Customer |
Role |
2020 - now |
Trainer for medical devices |
|
2020 - now |
RA manager |
|
2019 – now |
QA manager |
|
2019 – 2021 |
CE & ISO 13485 lead auditor |
|
2017 – now |
QA manager, setup/review CE files |
|
2011 – 2021 |
ISO 9001/13485/CMDCAS lead auditor |
|
2012 – 2019 |
Assist QA manager, consult on medical projects |
|
2014 – 2018 |
QA manager, review CE files |
|
2018 |
QA manager |
|
2017 – 2018 |
Software Tool Validation manager |
|
2016 – 2017 |
Setup FDA 21CFR part 11 QMS, resolve FDA scope audit issues |
|
2012 – 2017 |
MediSpirit |
Setup ISO 13485 QMS, CE file, Setup CFDA file |
2015 - 2016 |
Internal Lead auditor, train auditors, improve audit process |
|
2013 - 2014 |
Setup 2 CE files, made QMS CMDR compliant, QA officer |
|
2013 |
Maintenance ISO 13485 QMS for IVD product |
|
2011 – 2013 |
Setup FDA / ISO 13485 certified QMS |
|
2011– 2013 |
Setup CE file |
|
2010 – 2011 |
Setup and maintain ISO 9001/13485 certified QMS |
|
2010 – 2013 |
Setup ISO 13485 QMS and FDA compliant production line |
|
2009 |
Setup FDA / ISO 13485 certified QMS for IVD product |
|
2008 |
Setup QMS |
|
2008 |
Medical QA officer |
|
2007 |
Get FDA clearance on software device |
|
2007 |
QA & CM manager |
|
2006 |
Setup CMM-I compliant QMS |
|
2003 – 2005 |
Medical System QA officer |
|
2002 – 2003 |
Medical Software QA officer |
|
2001 |
Group lead SQA team /SPI coordinator |
|
2000 |
System QA officer |
|
1996 – 1999 |
Software QA officer |
|
1995 |
Dräger (ATOS Origin) |
System Test Engineer / Embedded Software Engineer |
1993 – 1995 |
Philips Medical, CV & MR (ATOS Origin) |
Embedded Software Engineer |
1993 |
Philips Nederland (ATOS Origin) |
Embedded Software Engineer |
1990 - 1991 |
Embedded Software Engineer |
|
1989 – 1990 |
Organon Technica (ATOS Origin) |
Embedded Software Engineer |
1988 |
Océ vd Grinten (ATOS Origin) |
Embedded Software Engineer |
1987 – 1988 |
Comdes |
Embedded Software Engineer |
1987 |
Volmac toptraining |
Trainee |