CAPA and RA Coach, Trainer
FEHLING INSTRUMENTS
Schlagwörter
Skills
webinars, SCRUM, Trident, FMEA, SQM, WDS, ERP, Dynamics, CAPA. MDR, MDSAP, Design Transfer, Normen 9001, 13485
Projekthistorie
05/2017
-
08/2020
* 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.
02/2020
-
04/2020
MDR Trainer
Carl Zeiss, Vision Care
12/2019
-
01/2020
CAPA Consultant and Coach
Medical Device Industry - Karl Storz SE & Co KG
11/2001
-
02/2019
Interim Director of RA/QM/TD
Medical Device Industry - MediGlobe GmbH
Project Lead MDR implementation
01/2019
-
01/2019
Interim Director of RA/QM/TD
Medical technology company Switzerland (customer does not want to be mentioned)
2019-01-15 - 2019-01-31
Task Force Mission "Investigation of a major audit finding
* Investigation of deviations on plastic injection molded parts
* Check the techn. documentation
* Revision of inspection plans (Verification)
* Process adaptation and process validation COMPANY
2019-01-15 - 2019-01-31
Task Force Mission "Investigation of a major audit finding
* Investigation of deviations on plastic injection molded parts
* Check the techn. documentation
* Revision of inspection plans (Verification)
* Process adaptation and process validation COMPANY
09/2018
-
12/2018
Interim Director of RA/QM/TD
Abbott Thoratec
CAPA expert medical device technology
* Conducting CAPA training, Root Cause Analysis, Investigation
Methods.
* Review of CAPAs opened based on audit findings.
* Update Design history files develop GAP-analysis acc. new MDR.
* Conducting CAPA training, Root Cause Analysis, Investigation
Methods.
* Review of CAPAs opened based on audit findings.
* Update Design history files develop GAP-analysis acc. new MDR.
03/2018
-
07/2018
Consultant MDSAP, Medical Device Single Audit Process, the FDA
Heidelberg Engineering
* Carrying out 23 internal audits, 13485: 2016
* Execution of several supplier audits for critical suppliers after 14791
risk management and the requirements of MDSAP.
* adaptation of all SOPs to the MDSAP requirements,
* Change Management
* Creating and running webinars to train all employees
13485: 2016 and MDSAP in German and English.
* Creation and modification of SOPs, AAs and Forms
* process validation
* Care of the Polarion system Registration of all audit discrepancies and determination
the CAPA activities.
* Review all product design documentations according MDR requirements, develop a questionnaire
for the production area to check the fulfillment of FDA-requiremnts (FDA human factor Guidance).
* Execution of several supplier audits for critical suppliers after 14791
risk management and the requirements of MDSAP.
* adaptation of all SOPs to the MDSAP requirements,
* Change Management
* Creating and running webinars to train all employees
13485: 2016 and MDSAP in German and English.
* Creation and modification of SOPs, AAs and Forms
* process validation
* Care of the Polarion system Registration of all audit discrepancies and determination
the CAPA activities.
* Review all product design documentations according MDR requirements, develop a questionnaire
for the production area to check the fulfillment of FDA-requiremnts (FDA human factor Guidance).
02/2017
-
05/2017
CAPA Coach
Dornier Medical Technic
* Review of existing CAPAs
* Preparation of QM audit TÜV Süd
* Training of QM staff
* Build and maintain the CAPA dashboard.
* Review processes based on the new MDR.
* Change Management
* Supplier audits
* Preparation of QM audit TÜV Süd
* Training of QM staff
* Build and maintain the CAPA dashboard.
* Review processes based on the new MDR.
* Change Management
* Supplier audits
04/2016
-
12/2016
QA and RA, SME, Coach
Maquet
* Creation, verification of SOPs, AA and Forms.
* Handling of CAPAs and deviations, Complaints and Non
Conformities.
* Review of the technical documentation
* Change Management
* Planning and execution of supplier audits
* Introduction of the supplier evaluation process.
* Verification of suppliers
* Risk assessment of the outsourced processes.
* Handling of CAPAs and deviations, Complaints and Non
Conformities.
* Review of the technical documentation
* Change Management
* Planning and execution of supplier audits
* Introduction of the supplier evaluation process.
* Verification of suppliers
* Risk assessment of the outsourced processes.
07/2015
-
10/2015
Agile expert
Novartis AG
* Introduction of the global agile methodology
* Training of SCRUM team members
* Training of SCRUM team members
07/2014
-
06/2015
Project Manager Trident Project
Zimmer-Biomet
* Project management / planning Trident projects in the areas with 5 part project leaders
Complaint Handling, Medical Device Reporting, Corrections & Removals,
Medical Device Tracking, PMS.
* Training Po-Systems AG, conversion from DIN EN ISO 24791 to 14791
Complaint Handling, Medical Device Reporting, Corrections & Removals,
Medical Device Tracking, PMS.
* Training Po-Systems AG, conversion from DIN EN ISO 24791 to 14791
04/2014
-
04/2014
Six Sigma Trainer Pharmaceuticals industry
Pharmaceutical industry
* Training engineers in SixSigma methods
08/2013
-
04/2014
Consultant Audit & CAPA
Johnson & Johnson
* Analysis of existing CAPAs medical technology.
* Processing CAPAs for FDA Audit.
* Change Management
* support the client during the preparation of the FDA
Audits and external audits as well as internal audits, review and
Development of practicable Löxsungen.
* Complaint management, claim handling, internal and external takeover
Complaints, processing of NCRs (non-conformity requests).
* Acquisition of NCRs in the CAPA process
* Perform legacy reviews from CAPAs to status quo
* Creation and modification of SOPs
* Review of CAPAs and preparation of remediation reports according to
Requirements of the FDA
* Leading the CAPA Review Board, supporting the external CAPA
Consultants in the development of different levels, monitoring
and monitoring the CAPA activities.
* Batch tracking in field action activities, monitoring and
Releases of the lock camp.
* Documentation of the return of batches from the
Quarantine storage.
Creation and maintenance of the necessary monitoring reports
* Assistance with strategic review, monitoring of
continuous improvement with project management methods,
effective communication with US and European companies in
Questions of quality.
* Introduction of practical design investigations, development and
Introduction of standard procedures, processes and systems for CAPA
Risk analysis and process FMEA.
* Processing CAPAs for FDA Audit.
* Change Management
* support the client during the preparation of the FDA
Audits and external audits as well as internal audits, review and
Development of practicable Löxsungen.
* Complaint management, claim handling, internal and external takeover
Complaints, processing of NCRs (non-conformity requests).
* Acquisition of NCRs in the CAPA process
* Perform legacy reviews from CAPAs to status quo
* Creation and modification of SOPs
* Review of CAPAs and preparation of remediation reports according to
Requirements of the FDA
* Leading the CAPA Review Board, supporting the external CAPA
Consultants in the development of different levels, monitoring
and monitoring the CAPA activities.
* Batch tracking in field action activities, monitoring and
Releases of the lock camp.
* Documentation of the return of batches from the
Quarantine storage.
Creation and maintenance of the necessary monitoring reports
* Assistance with strategic review, monitoring of
continuous improvement with project management methods,
effective communication with US and European companies in
Questions of quality.
* Introduction of practical design investigations, development and
Introduction of standard procedures, processes and systems for CAPA
Risk analysis and process FMEA.
09/2011
-
07/2013
Consultant, Coach
Brugg Cable Industry AG
* coaching of the CEO, development of the process map for all
Manufacturing processes and SQM processes.
* Conducting workshops with the management circle.
* Assistance in the outsourcing of ready-made garments to Poland.
* Construction of the QM system in Poland. Perform internal as well
Supplier audits for suppliers to the cable industry.
* Accompanying US American customer audits at Brugg Cable Industry AG.
Manufacturing processes and SQM processes.
* Conducting workshops with the management circle.
* Assistance in the outsourcing of ready-made garments to Poland.
* Construction of the QM system in Poland. Perform internal as well
Supplier audits for suppliers to the cable industry.
* Accompanying US American customer audits at Brugg Cable Industry AG.
01/2010
-
08/2011
Consultant supplier management
WDS GmbH
* Reorganization of the product portfolio, supplier management, ERP
software implementation
software implementation
06/2003
-
06/2009
ERP Manager
Instrument production company
ERP Manager - Setting up a Software House, CEO of the Softwarehouse
* Establishment and foundation of the group software house with branches in
Switzerland, USA and China.
* Top performers in the ERP environment. Introduction of Dynamics AX in 30
National companies. Microsoft Gold-Partner
* Establishment and foundation of the group software house with branches in
Switzerland, USA and China.
* Top performers in the ERP environment. Introduction of Dynamics AX in 30
National companies. Microsoft Gold-Partner
07/1990
-
12/1994
Executive Consulting
GmbH
* CEO, executive consulting, management and consulting
* IT- and HR Consulting
* IT- and HR Consulting
06/1984
-
06/1990
CIO automotive
Volvo
* CIO of the car manufacturer for the areas Truck / Car in the
Germany headquarters.
* Conversion of IT areas into a profit center.
* Building the IBM AVP organization with Volvo dealers.
* IT Merge Volvo Renault.
Carrying out the ISO 9001 certification at Renault-Truck Germany AG
as part of the Merge.Participation in the continuing education program for
Senior executives at Stevens Point University, Madison, Wisconsin,
UNITED STATES with the grade of PhD (industrial promotion)
Germany headquarters.
* Conversion of IT areas into a profit center.
* Building the IBM AVP organization with Volvo dealers.
* IT Merge Volvo Renault.
Carrying out the ISO 9001 certification at Renault-Truck Germany AG
as part of the Merge.Participation in the continuing education program for
Senior executives at Stevens Point University, Madison, Wisconsin,
UNITED STATES with the grade of PhD (industrial promotion)
Reisebereitschaft
Verfügbar in den Ländern
Deutschland, Österreich und Schweiz
