ID1016
Senior Consultant and Principal Advisor
BSc. ME
Available for: Tasks
Contact us for full CV
Competences
- Management.
- Change Management.
- Quality Management and Implementation.
- IT-system for QA.
- Process optimizing.
- Process validation.
- LEAN.
- GMP (Good Manufacturing Process).
- Project Management.
- Program Management.
- Audits/ Inspections (FDA / MDSAP) TGA, CFDA and others.
- Management Review.
Key results
Management of corporate QA function in both a large Danish and US Medical Device/IVD company Securing compliance and well performed Audits – no major observations.
Aligning QA strategies with Business goals – Training and implementation of SOP’s in global scale MDSAP certification, Legal entity transfer, Preparing for IVDR and MDR.
Standards
Extensive knowledge in:
- ISO13485 og 14971
[Medical Device QS and Risk Management] - FDA regulation
[CFR part 820, CFR part 11, UDI] - Guideline
[ICH Q7, Q9 and Q10, GAMP 5, GHTF Process validation]
Personal Characteristics
He is a pragmatic and straight forward person that believes in an open and honest dialogue, he enjoys working with others.
Has many years hands-on experience in implementation and integration of management systems and LEAN.
Spends his free time with family, boating, skiing, diving, kiting and running.
Contact
Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13
contact@medicologic.com
Medicologic-profile
Where to find us
Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com
Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com