06.09.2022 aktualisiert
HH
100 % verfügbar
CAPA Consultant and Coach, Interim Director of RA/QM/TD, Interim Director of RA/QM/TD
Trin, Schweiz
Deutschland +2
Skills
ERPScrumFMEAMedical DeviceCAPA-ManagementCoach & TrainerMDR (Medical Device Regulation)MDSAPQualität Management
webinars, SCRUM, Trident, FMEA, SQM, WDS, ERP, Dynamics, CAPA. MDR, MDSAP, Design Transfer, Normen 9001, 13485
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
* Responsible for FDA readyness, creating processes, Work instructions and forms.
* process validation
* Change Management
* Review of 510K filing applications before plausibility and
Completeness. Introduction and training of the Designcontrol process according to 21
CFR 820.30 and 13485: 2016, MDR.
* Creating a response letters to remove a 483 from the FDA,
* Conduct supplier audits.
* Structure of the complaint system.
* Audit Preparation DQS Audit, 13485: 2016, Inspection Preparation FDA 21 CFR
820,100, audit preparation new MDR by Notified Body.
* process validation
* Change Management
* Review of 510K filing applications before plausibility and
Completeness. Introduction and training of the Designcontrol process according to 21
CFR 820.30 and 13485: 2016, MDR.
* Creating a response letters to remove a 483 from the FDA,
* Conduct supplier audits.
* Structure of the complaint system.
* Audit Preparation DQS Audit, 13485: 2016, Inspection Preparation FDA 21 CFR
820,100, audit preparation new MDR by Notified Body.