internal Auditor
BMW Welt AG
Schlagwörter
Skills
ISO 13485, ISO 60601, ISO 62304, ISO 14971, ISO 9001, DPM, Intranet, quality management system, SAP, MS Office, Excel, Word, PowerPoint, Outlook, Viastore, megalux, WissIntra, DMS, Agile, ELO, Adobe programms, Photoshop CS, Design
Projekthistorie
07/2014
-
11/2021
* Create the audit plans for internal audits in all departments
* conducting internal audits in all departments
* Create the audit reports
* Wrap-up of internal audits
* Acquisition of improvement measures
* Prepare the company for ISO 14001 certification
* Prepare the company for certification OHSAS 1800
* conducting internal audits in all departments
* Create the audit reports
* Wrap-up of internal audits
* Acquisition of improvement measures
* Prepare the company for ISO 14001 certification
* Prepare the company for certification OHSAS 1800
01/2004
-
11/2021
Auditor
LRQA Europe
* implementation of a certification audit for ISO 9001
* implementation of a certification audit for ISO 14001
* implementation of a certification audit for ISO 13485
* implementation of a certification audit for OHSAS 18001
* implementation of a certification audit for ISO 50001
* implementation of a certification audit for ISO 14001
* implementation of a certification audit for ISO 13485
* implementation of a certification audit for OHSAS 18001
* implementation of a certification audit for ISO 50001
10/2018
-
03/2020
Head of Quality / QMB
Xenios AG
* Use as an independent QMB
* MDR readiness for all plants
* Further development and maintenance of a QM manual and cooperation
* Establishment and maintenance of a system for error management, review and
approval
* Development and maintenance of a system for complaint management, review and
approval of SOPs and as QMB in the Rekla Board
* Establishment and maintenance of a system for validation and qualification,
review and approval of SOPs
* Establishment and maintenance of a system for change management, review and
release of SOPs
* Development and maintenance of a training system
* Management evaluation and quality planning, review and approval of the SOPs and
report as QMB
* Preparing the organization for FDA audits
* Creation and maintenance of quality-relevant documents
* Carrying out internal audits according to FDA standard and MDR standard
* Conduct employee training and awareness-raising workshops on FDA audits and MDR
standards
* MDR readiness for all plants
* Further development and maintenance of a QM manual and cooperation
* Establishment and maintenance of a system for error management, review and
approval
* Development and maintenance of a system for complaint management, review and
approval of SOPs and as QMB in the Rekla Board
* Establishment and maintenance of a system for validation and qualification,
review and approval of SOPs
* Establishment and maintenance of a system for change management, review and
release of SOPs
* Development and maintenance of a training system
* Management evaluation and quality planning, review and approval of the SOPs and
report as QMB
* Preparing the organization for FDA audits
* Creation and maintenance of quality-relevant documents
* Carrying out internal audits according to FDA standard and MDR standard
* Conduct employee training and awareness-raising workshops on FDA audits and MDR
standards
05/2018
-
10/2018
Interim QA/RA Director Germany
STS Medical Group
* Construction and training of regulatory department in all plants
* Construction and training of quality department in all plants
* Regulatory approvals worldwide
* GAP analysis
* MDR readiness for all plants
* Preparation in all plants for ISO 13485: 2016, ISO 14971 and MDR certification
* CE approval
* Revision of the documents regarding the new MDR
* Validations for sterilization, transport, process and machines
* Construction and training of quality department in all plants
* Regulatory approvals worldwide
* GAP analysis
* MDR readiness for all plants
* Preparation in all plants for ISO 13485: 2016, ISO 14971 and MDR certification
* CE approval
* Revision of the documents regarding the new MDR
* Validations for sterilization, transport, process and machines
04/2017
-
04/2018
External RA Manager
Heraeus Medical GmbH
* Regulatory approvals worldwide
* MDR readiness for all plants
* Self-responsible development of the structure of the technical documentation
based on the requirements of the new MDR for medical class III products (bone
cementation)
* Product Life Cycle implementation
* GAP analysis
* Consultation on the development of a coating process for technical documentation
for medical class III products (bone cementation)
* CE approval and approval for the American area
* Revision of the documents regarding the new MDR
* MDR readiness for all plants
* Self-responsible development of the structure of the technical documentation
based on the requirements of the new MDR for medical class III products (bone
cementation)
* Product Life Cycle implementation
* GAP analysis
* Consultation on the development of a coating process for technical documentation
for medical class III products (bone cementation)
* CE approval and approval for the American area
* Revision of the documents regarding the new MDR
11/2016
-
06/2017
External Quality Manager for class III products
Pulsion AG
* Regulatory approvals worldwide
* Production, modification and testing of accompanying documentation (production
and development) according to ISO 13485 and ISO 14971
* Cooperation with the development and RA department
* Product Life Cycle implementation
* GAP analysis
* Design Change Control and Risk Management
* CE approval and approval for the American area
* Revision of the documents regarding the new MDR
* Creation of labels according to ISO 13485 for all countries
* Revision of the design transfer process
* Coordination of the release of the labeling documents
* Creating Labels according to UDI
* Creating project management process
* Production, modification and testing of accompanying documentation (production
and development) according to ISO 13485 and ISO 14971
* Cooperation with the development and RA department
* Product Life Cycle implementation
* GAP analysis
* Design Change Control and Risk Management
* CE approval and approval for the American area
* Revision of the documents regarding the new MDR
* Creation of labels according to ISO 13485 for all countries
* Revision of the design transfer process
* Coordination of the release of the labeling documents
* Creating Labels according to UDI
* Creating project management process
04/2015
-
12/2016
Consultant for orthopedic implants
De Puy Synthes a company of J&J
* Creating risk analysis in accordance with ISO 13485 / ISO 14971 and ISO 60601-1
* CE approval and approval for the American area
* Creating DCR`s / DCO`s ISO 13485 / ISO 14971and ISO 60601-1
* Project management
* Create the related documents
* GAP analysis
* Regulatory approvals worldwide
* Processing of CAPA`s and NCR`s
* reviewing and editing the documentation aspects of FDA regulations
* Design Change Control
* Create, optimize and monitor processes in different plants
* Support Manufacturing Engineer to complete Production Risk Management Documents in compliance
with ISO 14971:2013 - Medical devices - Application of risk management to medical
devices.
* Create and Management of Manufacturing Process Information.
* CE approval and approval for the American area
* Creating DCR`s / DCO`s ISO 13485 / ISO 14971and ISO 60601-1
* Project management
* Create the related documents
* GAP analysis
* Regulatory approvals worldwide
* Processing of CAPA`s and NCR`s
* reviewing and editing the documentation aspects of FDA regulations
* Design Change Control
* Create, optimize and monitor processes in different plants
* Support Manufacturing Engineer to complete Production Risk Management Documents in compliance
with ISO 14971:2013 - Medical devices - Application of risk management to medical
devices.
* Create and Management of Manufacturing Process Information.
08/2014
-
02/2015
Project Leader for class III products
Maquet Cardiopulmonary GmbH - Getinge Group
* Optimization of processes in all plants ISO 13485 / ISO 9001
* Project management with a team of 6 employees
* Creating, monitoring and introducing new processes ISO 13485 / ISO 14971
* Create the corresponding documents ISO 13485 / ISO 9001 / ISO 14971
* training of staff in all plants (Germany / Turkey) ISO 13485
* Acquisition of improvement measures ISO 13485
* automation of production processes ISO 13485 / ISO 9001
* Execution of various CAPA / NCR ISO 13485
* Project management with a team of 6 employees
* Creating, monitoring and introducing new processes ISO 13485 / ISO 14971
* Create the corresponding documents ISO 13485 / ISO 9001 / ISO 14971
* training of staff in all plants (Germany / Turkey) ISO 13485
* Acquisition of improvement measures ISO 13485
* automation of production processes ISO 13485 / ISO 9001
* Execution of various CAPA / NCR ISO 13485
07/2012
-
03/2013
Quality Manager
WEBO Tooling GmbH
* Create measurement programs (Zeiss Calypso)
* Create PPAP's
* Maintenance of the Quality Manual
* Training of QA personnel
* Training of production staff
* Maintain documentation and integration of the documentation in the Intranet
* incorporation of the QM
* Create PPAP's
* Maintenance of the Quality Manual
* Training of QA personnel
* Training of production staff
* Maintain documentation and integration of the documentation in the Intranet
* incorporation of the QM
06/2011
-
08/2012
Quality Manager
Blaser GmbH
* Create measurement programs (Zeiss Calypso)
* Create PPAP's
* Maintenance of the Quality Manual
* Training of QA personnel
* Maintain documentation and integration of the documentation in the Intranet
* incorporation of the QMB
* Create PPAP's
* Maintenance of the Quality Manual
* Training of QA personnel
* Maintain documentation and integration of the documentation in the Intranet
* incorporation of the QMB
09/2011
-
03/2012
Training for quality manager and auditor
TÜV Rheinland
Development of a quality management system: fundamentals of quality
management, quality management principles, DIN EN ISO 9000 ff, processes in
the QM
Organization of quality and auditing activities: organization and coordination
of measurement, testing, monitoring of processes and products / quality
testing, Fundamentals of
Control of nonconformity, accreditation, certification, auditing,
communication
management, quality management principles, DIN EN ISO 9000 ff, processes in
the QM
Organization of quality and auditing activities: organization and coordination
of measurement, testing, monitoring of processes and products / quality
testing, Fundamentals of
Control of nonconformity, accreditation, certification, auditing,
communication
01/2000
-
09/2004
Quality Assurance
Faller KG
* In-house training for punch
* Training for Quality Control and Quality Assistant with completion IHK
* Preparation of reports
* Creation of test certificates
* Check the Braille
* in-process controls
* Training for Quality Control and Quality Assistant with completion IHK
* Preparation of reports
* Creation of test certificates
* Check the Braille
* in-process controls
Reisebereitschaft
Weltweit verfügbar
