ID1063
Senior Compliance and Audit Consultant
MSc, Chemical Engineering, DTU
Available for: Part-time, full-time, tasks
Contact us for full CV
Competences
- Quality Management
- Medical Device QMS
- Management representative
- In- and external audit and inspection
- Audit Management and execution
- Supplier Quality Management and audit
- Quality tools, i.e. CAPA, NCR, MR
- QMS implementation
- Lead auditor
Key results
- Have held positions as VP QA&RA, Director Quality, Director QA and GM Quality
- I have during my career been responsible for certification and recertification projects, driving audits and inspection, including FDA inspections and MDSAP audits
- I have been a leader for both small and large teams, including subteams and managers
- This includes both management and driving all aspects of medical devices compliance and QA
- I am used to working both nationally as well as truly globally
Software/Standards
Extensive knowledge in:
- ISO13485
- FDA 21CFR part 820
- MDSAP
- MDR/MDD
Software skills:
- SAP
- Documentum
- Enovia
- Salesforce
- MS Office and SharePoint
Personal Characteristics
He is someone who:
– Selfdrive and self motivated
– Work both as a team player or by himself
– Can work with all levels in organizations
– Is driven by seeing the results
– Good business understanding
– Analytical
Whit a background as a chemist, he has spent most of his professional lige within quality.
He have had successes in driving, maintaining and implementing quality systems in a pragmatic way balancing both compliance and business needs.
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
![MF_profil](http://medicologic.com/newsite/wp-content/uploads/2020/10/MF_profil.png)
Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com
![um5gVdaQ_400x400](http://medicologic.com/newsite/wp-content/uploads/2020/10/um5gVdaQ_400x400.jpg)
Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com