Norbert Helmke

Norbert Helmke

Project Manager & Team Lead, Zimmer Company

Ich bin aktiv auf Stellensuche
 

Currently employed at Novartis, Synthes

Previous: Novartis, Janssen Vaccines, Allergopharma, Biedermann-Motech, Paul Hartmann AG, Synthes, Zimmer Company, Normed a Zimmer Company, Beckman Coulter, Beckman Coulter Biomedical GmbH, Bombardier Transportation, XTREME Technologies GmbH, Mammoet, K Prüfservice GmbH, Adecco Personnel Services, Opel, xxx, SAP module, MANPOWER GmbH, Norbert Helmke, IT-Services and Solution GmbH, Service GmbH, AXA colonia, nationwide, media center, Adecco Training, Media, Fa. SCHAUDT Schleifmaschinen, Behr, air condition

 

Previous: IBM, ISO, Media Center, Technical College For Mechanical Engineering, Max Eight, Abendschule, Goetheschule, Junior High School

 

    Summary

    I look fo a permant role as Project Director world wide. Skills, knowledge and experiences • Team leader R & D • Project manager software development rail vehicles • Project manager ultraviolet light • Project manager (construction site responsibility) and HSE for chemical industry • Project manager logistics, supply chain automotive supplier industry • Project manager introduction of new corporate identity of automotive industry • Interim manager Managing Director Performance strengths • Responsible, high degree of independence • Logical, process-oriented and strategic thinking and acting • Customer-oriented and independent working • Assertiveness and strong communicative skills • Team oriented, appropriate and targeted work • Organization and presentation • Creativity and design

Experiences

Interim Director Projekt Manager

At Novartis

From Mai 2019 to Present
Task: * Lead project Teams (international) * Lead projects for the R&D department * Risk Management * Change Management * Presentation for the upper Management
 

Team Lead

At Synthes

From August 2015 to Present
To work with Suppliers / Manufacturing Sites to document the process flow To work with Suppliers / Manufacturing Sites to create the Production Risk Assessment To work with Suppliers / Manufacturing Sites on the different requests coming from the Tech Files SME's ...
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Packaging Transfer Team Lead

At Novartis

From Oktober 2018 to April 2019
Novartis Basel / Swiss (contract) Device &; Packaging Transfer Team Lead Professional Experience: Job Purpose (State in one sentence the overall objective of the role) Manages Device &; Secondary Packaging related to transfer and launch activities for assigned projects. Leads BTDM ...
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Technical Manager

At Janssen Vaccines

From April 2018 to Oktober 2018
POSITION SUMMARY: The Technical Manager has overall accountability for ensuring fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes and products into the supply chain and the global market place. Areas of key responsibility...
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Project Manager

At Allergopharma

From November 2017 to März 2018
Design and modification of Quality Management Manual for Certification of ISO 13485:2016 and CE Develop all Documents for RA and R&D Process implement R&D Design of documents for CE and IVD Subprojectlead (IVD Allergeninstrument) IVD-guideline 98/79/EC MDD...
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Business Process Manager

At Biedermann-Motech

From August 2017 to Oktober 2017
Medical Devices Class III, ISO 13485 Development and improvement of existing production and development processes Conception, design, implementation, testing and introduction of new processes Construction Process Documentation Kanban Six Sigma implants and...
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Project Manager R&D

At Paul Hartmann AG

From März 2017 to August 2017
Medical Device Class I Management/coordination of development projects and product change projects in the area of Incontinence management Responsibility for material product specification and their maintenance Production and maintenance of the technical documentation (Product Risk...
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Project Manager Manufacturing Process Information

At Synthes

From August 2015 to Februar 2017
(MPI) and Quality Management, Class I, IIa, IIb Engineering Project Manager / CAPA Specialist To work with Suppliers / Manufacturing Sites to document the process flow Monitoring performance by gathering relevant data and statistical reports Manage CAPA/NCR activities, acting as...
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Project Manager & Team Lead

At Normed a Zimmer Company

From Oktober 2014 to Juli 2015
Project Manager / Team Lead DHF, Quality Management Class I, IIa, IIb (Remediation of the Design History Files for the FDA) / CAPA Specialist resource planning and supervision Technical documentation Document management Leading, developing, motivating and managing the work...
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Project Manager & Team Lead

At Zimmer Company

From Oktober 2014 to Juli 2015
(Remediation of the Design History Files for the FDA) resource planning and supervision Technical documentation Document management Work with the FDA (21CFR Part820) QM ISO 13485 Experience with ISO 10007 510K Creation of Project plans and Milestone...
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Project Manager & Sub Team Lead

At Beckman Coulter Biomedical GmbH

From April 2013 to September 2014
(contract) Project Manager / Sub Team Lead (Clinical Automation) and Quality Management, In-vitro-Diagnostikum (IVD) In-vitro Diagnostic Directive (IVDD) or Directive 98/79/EC resource planning and supervision Looking at ways to reduce waste and increase efficiency ...
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Project Manager & Sub Team Lead

At Beckman Coulter

From April 2013 to September 2014
resource planning and supervision Technical documentation Document management Creation of Project plans and Milestone supervision Coordination of construction, production, purchase, logistic. Drawing Inspection Concept Inspection Design Inspection Kaizen ...
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Project leader

At Bombardier Transportation

From Januar 2012 to April 2013
Software Change Request Budget tracking Coordination of software development, testing, quality, logistic Engineering Budget Request Creation of project plans and milestone supervision resource planning and supervision Technical documentation Document management ...
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Project leader

At Bombardier Transportation

From Januar 2012 to April 2013
Software Change Request CAPA Specialist Budget tracking Lead, direct and manage the communication between the departments Monitoring performance by gathering relevant data and statistical reports Follow all company's filed procedures and protocols Cooperate with other line...
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Project leader & Quality Management

At XTREME Technologies GmbH

From Februar 2011 to November 2011
Implementation and Optimization of processes Implementation of Configuration- and Instancemanagement Quality control of prototypes Supply management Creation of Project plans and Milestone supervision Planning and performing of Power upgrades of different product lines ...
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Project leader

At XTREME Technologies GmbH

From Februar 2011 to November 2011
Implementation and Optimization of processes Implementation of Configuration- and Instancemanagement Quality control of prototypes Supply management Creation of Project plans and Milestone supervision Planning and performing of Power upgrades of different product lines ...
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Project manager

At Mammoet

From Juli 2009 to Februar 2011
Herrmann+Laux Personnel Leasing : project management, documentation, administration back office, HSE, claim management, resource planning, change management, project controlling, measurement reports, claim management worked with steel metal and aluminium worked with cast iron worked with...
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Project manager

At Mammoet

From Juli 2009 to Februar 2011
Herrmann+Laux Personnel Leasing : project management, documentation, administration back office, HSE, claim management, resource planning, change management, project controlling, measurement reports, claim management
 

Leiter Projektmanagement

At K Prüfservice GmbH

From April 2009 to Juni 2009
Head of Project coordination, administration, invoicing
 

Project coordination

At K Prüfservice GmbH

From April 2009 to Juni 2009
Project coordination, administration, invoicing
 

Senior Project Manager Logistics

At Adecco Personnel Services

From März 2007 to Januar 2009
Senior Project Manager Logistics at Continental Teves Frankfurt SAP module: MM, SD Project- and Procure Management / Logistics (start-ups) for a manufacturer of car equipment (automotive industry) Perform new plans Perform initial series of discussions with the relevant authorities...
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Senior Project Manager Logistics

At Adecco Personnel Services

From März 2007 to Januar 2009
Senior Project Manager Logistics at Continental Teves Frankfurt SAP module: MM, SD Project- and Procure Management / Logistics (start-ups) for a manufacturer of car equipment (automotive industry) Perform new plans Perform initial series of discussions with the relevant...
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Projektleiter

At Opel

From August 2006 to März 2007
(Deadline coordination and auditing) SAP modules: SD, FI, MM Create lists of priorities for Opel, Saab and Chevrolet Network planners. Follow-Up of VH master data, data collection, if necessary processing of dealer-data. Creation of Status Report on a monthly / weekly basis. Auditing and...
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Projektleiter

At Opel

From August 2006 to März 2007
(Deadline coordination and auditing) SAP modules: SD, FI, MM Create lists of priorities for Opel, Saab and Chevrolet Network planners. Follow-Up of VH master data, data collection, if necessary processing of dealer-data. Creation of Status Report on a monthly / weekly basis. Auditing and...
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Independent Recruiter

At SAP module

From Mai 2004 to Juli 2006
Distribution of national personnel services, direct contact of potential candidates, candidate management. Recruitment of candidates, conducting interviews, and presenting candidates at the customer
 

Independent Recruiter

At xxx

From Mai 2004 to Juli 2006
SAP module: SD Distribution of national personnel services, direct contact of potential candidates, candidate management. Recruitment of candidates, conducting interviews, and presenting candidates at the customer
 

Marketing assistant

At MANPOWER GmbH

From Januar 2004 to April 2004
Employed on a regular basis at MANPOWER GmbH Frankfurt/Höchst - Personnel Service: Misumi Europa GmbH (mechanical standard components supplier.). SAP module: MM Marketing assistant: responsible for the acquisition of new customers, implementation of new marketing strategies, fair planning and...
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Marketing assistant

At MANPOWER GmbH

From Januar 2004 to April 2004
Employed on a regular basis at MANPOWER GmbH - Personal Service: Misumi Europa GmbH (mechanical standard components supplier.). SAP module: MM Marketing assistant: responsible for the acquisition of new customers, implementation of new marketing strategies, fair planning and mailings,...
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Projektleiter

At xxx

From Januar 2003 to Dezember 2003
self-service work at a confectionery manufacturer
 

Recruiter

At Norbert Helmke

From Januar 2003 to Dezember 2003
self-service work at a confectionery manufacturer
 

IBM, Düsseldorf

IBM

From Januar 2001 to September 2003
 

Consultant

At IT-Services and Solution GmbH

From Juli 2000 to Dezember 2002
Employed on a regular basis at IT-Services and Solution for Lotus Notes and E-Commerce, Leader of the QM-Team, Leader of the back office, responsible for the budget, arrangement of travel and other project related events, co-ordination of workshops, managing the purchase order process,...
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Consultant

At IT-Services and Solution GmbH

From Juli 2000 to Dezember 2002
Employed on a regular basis at IT-Services and Solution for Lotus Notes and E-Commerce, Leader of the QM-Team, Leader of the back office, responsible for the budget, arrangement of travel and other project related events, co-ordination of workshops, managing the purchase order process,...
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IBM, Düsseldorf

IBM

From Dezember 1999 to Januar 2001
 

Projektleiter

At Service GmbH

From März 1999 to Juni 2000
Employed on a regular basis at International Mail- Responsible for the VISIP Software tool (distribution), International user support (U.K., Belgium, Washington D.C., Singapore, Austria), purchasing of hardware, Cognos Impromptu reports (Oracle database), Ad-hoc Reports
 

xxx

At Service GmbH

From März 1999 to Juni 2000
Employed on a regular basis at International Mail- Responsible for the VISIP Software tool (distribution), International user support (U.K., Belgium, Washington D.C., Singapore, Austria), purchasing of hardware, Cognos Impromptu reports (Oracle database), Ad-hoc Reports
 

Technical consultant

At MANPOWER GmbH

From November 1997 to Februar 1999
Employed on a regular basis at MANPOWER GmbH - Personnel Service: WestLB and Aachener und Münchner Versicherung (insurance companies): Support Agent - User Support Office 95/97, Windows 3.x and NT 4.0 Reutersterminal, Trade Wizard, Installation of Hard- and Software, Support of Exchange- und...
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Berater

At MANPOWER GmbH

From November 1997 to Februar 1999
Employed on a regular basis at MANPOWER GmbH Köln - Personnel Service: WestLB and Aachener und Münchner Versicherung (insurance companies): Support Agent - User Support Office 95/97, Windows 3.x and NT 4.0 Reutersterminal, Trade Wizard, Installation of Hard- and Software, Support of Exchange-...
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Freelancer

At AXA colonia

From April 1997 to Oktober 1997
Freelancer - nationwide system administration and user support at an insurance company and a bank for the operating systems Windows 3.1x / 95 / NT 4.0, MS Mail, Rumba 4.0, HobLink 3270, Novell 3.11 and 4.11
 

Projektleiter

At nationwide

From November 1996 to Oktober 1997
Freelancer - nationwide system administration and user support at an insurance company and a bank for the operating systems Windows 3.1x / 95 / NT 4.0, MS Mail, Rumba 4.0, HobLink 3270, Novell 3.11 and 4.11
 

General Manager & sales manager

At media center

From Januar 1996 to März 1997
General Manager and sales manager at media center Bonn GmbH, (planning of curriculum, concepts, budget, calculation, acquisition, human resources and training)
 

General Manager & sales manager

At media center

From Januar 1996 to Oktober 1996
General Manager and sales manager at media center Bonn GmbH, (planning of curriculum, concepts, budget, calculation, acquisition, human resources and training)
 

ISO, Stuttgart

ISO

From März 1995 to September 1996
 

ISO, Stuttgart

ISO

From März 1995 to März 1996
 

ISO, Stuttgart

ISO

From März 1995 to März 1996
 

ISO, Stuttgart

ISO

From März 1995 to März 1996
 

ISO, Stuttgart

Technical Engineer, ISO

From März 1995 to März 1996
 

ISO, Stuttgart

ISO

From März 1995 to März 1996
GxP experience, and knowledge of supplier Knowledge of GxP, ISO 13485and local quality regulatory requirements. Remediation for the FDA Interface for RA Interface for the QM Design Control
 

ISO, Stuttgart

IHK, ISO

From März 1995 to März 1996
 

ISO, Stuttgart

ISO

From März 1995 to Februar 1996
 

ISO, Stuttgart

ISO

From März 1995 to Februar 1996
GxP experience, and knowledge of supplier Knowledge of GxP, ISO 13485and local quality regulatory requirements. Experience with ISO 14971 Experience with ISO 13485 CAPA Process implantation Process optimizing Complainmanagement implants and screws of...
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ISO, Stuttgart

ISO

From März 1995 to Februar 1996
Management Training for Leadership Training for the - Quality management process - Tools for the Quality management - optimize of the company processes Main Focus Team Lead Projektmanager * Projectmanager * Requirements Engineer * ...
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Trainer

At Media

From Oktober 1994 to Dezember 1995
Trainer at media GmbH Stuttgart (Computer training (Office, PageMaker, AutoCAD 13, 3D-Studio, Microstation CAD, Windows 3.11 for Workgroups, Windows 95, DOS 6.2 and Windows NT)
 

Trainer

At Media

From August 1994 to Dezember 1995
Trainer at media GmbH Stuttgart (Computer training (Office, PageMaker, AutoCAD 13, 3D-Studio, Microstation CAD, Windows 3.11 for Workgroups, Windows 95, DOS 6.2 and Windows NT)
 

Media Center, Stuttgart

media center

From August 1994 to Oktober 1994
 

Designer

At Fa. SCHAUDT Schleifmaschinen

From Oktober 1990 to Dezember 1993
SCHAUDT Schleifmaschinen in Stuttgart-Hedelfingen (
 

Designer

At Fa. SCHAUDT Schleifmaschinen

From Oktober 1990 to Dezember 1993
SCHAUDT Schleifmaschinen in Stuttgart-Hedelfingen ( worked with steel metal and aluminium worked with cast iron worked with cast aluminium worked with sheet metal
 

Designer

At Behr

From Juli 1987 to September 1990
Designer in the development department for air condition and radiators (tanks, trucks) at the Süddeutsche Kühlerfabrik Julius Behr, Stuttgart
 

Designer in the development department

At air condition

From Juli 1987 to September 1990
and radiators (tanks, trucks) at the Süddeutsche Kühlerfabrik Julius Behr, Stuttgart worked with steel metal and aluminium worked with cast iron worked with cast aluminium worked with sheet metal
 

Max Eight, Kassel

Technical Engineer, Max Eight

From August 1985 to Juni 1987
 

Abendschule, Kassel

Abendschule

From 1982 to 1984
für Berufstätige in Kassel (night school). Degree: First public examination at secondary school
 

Abendschule, Kassel

Abendschule

From 1982 to 1984
für Berufstätige in Kassel (night school). Degree: First public examination at secondary school
 

Skills

 
  • 21CFR820
  • 3D Studio
  • 510(k)
  • Administration
  • Aldus Pagemaker
  • Audit
  • Autocad
  • back office
  • Show all skills (141)

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