Senior Product Compliance Manager
Workaround GmbH
Schlagwörter
Produktkonformität
Autocad
Agile Methodologie
Confluence
Jira
Microsoft Project
Microsoft Visio
Regulatorische Wissenschaften
SAP Applications
SQL
Skills
Regulatory knowledge, Product compliance, Agile methodology, JIRA; Confluence AUTOCAD, DIALUX, Excel, Microsoft Office, Powerpoint, MS PROJECT, VISIO, Word, SAP, SQL
Projekthistorie
06/2020
-
bis jetzt
Ensure certification of product portfolio
Enable global market access to product portfolio by ensuring compliance with international standards
Project management of external testing and certification partners
Validate engineering design to ensure early-stage product compliance
Setting up test devices to ensure the devices are prepared for the certification
HW Quality management
Enable global market access to product portfolio by ensuring compliance with international standards
Project management of external testing and certification partners
Validate engineering design to ensure early-stage product compliance
Setting up test devices to ensure the devices are prepared for the certification
HW Quality management
10/2019
-
04/2020
Product Compliance Manager
eGym GmbH
eGym GmbH, Munich (Germany)
* Leading Product Compliance processes (RED, LVD Safety, EMC, WEEE, ROHS, REACH...) for
global market.
* Product design control according to regulations and standards.
* Plan, build, & implement a continuously testing program to meet the needs of quality and compliance
requirements.
* Work with internal business owners and external organizations to maintain strategic requirements and
time frames for product compliance policies/processes, and oversee their implementation.
* Organize customer support, document storage and retrieval, project ownership and time
management.
* MDR EU 2017/745 medical device regulation works
* ISO 13485 Medical device quality system works
* JIRA; Agile methodology project management
* Leading Product Compliance processes (RED, LVD Safety, EMC, WEEE, ROHS, REACH...) for
global market.
* Product design control according to regulations and standards.
* Plan, build, & implement a continuously testing program to meet the needs of quality and compliance
requirements.
* Work with internal business owners and external organizations to maintain strategic requirements and
time frames for product compliance policies/processes, and oversee their implementation.
* Organize customer support, document storage and retrieval, project ownership and time
management.
* MDR EU 2017/745 medical device regulation works
* ISO 13485 Medical device quality system works
* JIRA; Agile methodology project management
04/2015
-
10/2019
R&D Senior Specialist
Arçelik Electronics plant; BEKO, GRUNDIG
Arçelik Electronics plant, İstanbul (Turkey) BEKO, GRUNDIG
* Test and Certification of electrical appliances.
* Product compliance; CE marking expert
* IEC 60065, IEC 62368 , IEC 60335 Test and certification
* Project management
* Risk assessment specialist
* Fire investigation expert
* Energy labelling engineering and certification expert
* IEC accreditation works specialist, ISO 17025 accreditation works
* EN 71 Toy Safety
* Six Sigma Green Belt
* Test and Certification of electrical appliances.
* Product compliance; CE marking expert
* IEC 60065, IEC 62368 , IEC 60335 Test and certification
* Project management
* Risk assessment specialist
* Fire investigation expert
* Energy labelling engineering and certification expert
* IEC accreditation works specialist, ISO 17025 accreditation works
* EN 71 Toy Safety
* Six Sigma Green Belt
04/2013
-
04/2015
Senior Design Group Chief
Berksan Engineering
Berksan Engineering, İstanbul (Turkey)
* Electrical systems (weak current, low current and medium voltage) design responsible multiple
projects (Cairo International airport, Kuntesevo multifunctional building, etc.. each over 150.000m2)
* Managing the team and coordination with other disciplines (architecture, mechanical, fire..etc).
* Communication and relations with main construction companies and local authorities.
* Electrical systems (weak current, low current and medium voltage) design responsible multiple
projects (Cairo International airport, Kuntesevo multifunctional building, etc.. each over 150.000m2)
* Managing the team and coordination with other disciplines (architecture, mechanical, fire..etc).
* Communication and relations with main construction companies and local authorities.
04/2011
-
04/2013
Estimation and Planning Chief
Berksan Engineering
Berksan Engineering, İstanbul (Turkey)
* Managing all offers for international and national projects (airports, power plants, offices, hotels,
factories, each tender amount 1 million $)
* Coordination and relation with different main construction companies
* Responsible for customer requirements, first point of contact for the customer.
* Managing all offers for international and national projects (airports, power plants, offices, hotels,
factories, each tender amount 1 million $)
* Coordination and relation with different main construction companies
* Responsible for customer requirements, first point of contact for the customer.
07/2009
-
04/2011
Construction Chief
Berksan Engineering
Berksan Engineering, Moscow (Russia)
* Project management of all electrical systems designs, approvals, material orders and installations
for a multifunctional building in the centre of Moscow (Tsvetnoy Boulevard project 120.000m2)
* Coordination and relation with other disciplines (architecture, mechanical, fire..etc).
* Managing local approvals
* Managing progress reports
* Project management of all electrical systems designs, approvals, material orders and installations
for a multifunctional building in the centre of Moscow (Tsvetnoy Boulevard project 120.000m2)
* Coordination and relation with other disciplines (architecture, mechanical, fire..etc).
* Managing local approvals
* Managing progress reports
08/2006
-
07/2009
Design Engineer
Berksan Mühendislik
Berksan Mühendislik, Moscow (Russia)
* Responsible for the whole electrical systems design for below buildings:(power distribution, lighting
design, fire alarms system, CCTV system, Security access system, etc...)
* Coordination and relation with other disciplines.
* Responsible for the whole electrical systems design for below buildings:(power distribution, lighting
design, fire alarms system, CCTV system, Security access system, etc...)
* Coordination and relation with other disciplines.
Zertifikate
ROHS REACH
INTERTEK
2021
ISO 9001 EN Internal Auditor
TÜV SÜD
2020
IS0 13485 Quality Management System
ADVIQUAL
2020
IEC-EN 60335
ÖZCAN TECHNIC
2019
GENERAL REGULATORY TRAINING
INTERTEK
2018
IEC EN 62368
INTERTEK
2017
Reisebereitschaft
Weltweit verfügbar
