cv (en)
maik roenneburg (cv)
Personal details
- Born on 10.07.1960 in Hamburg
- Unmarried, one daughter
- Nationality: German
- Resident in: Eltville / Rhein
Education and training
- Dipl.-Ing. Automotive, Production and Process Engineering (Braunschweig)
- Dipl.-Ing. Environmental and Hygiene Engineering (Giessen)
- Certified Project Management Professional, PMI (IIL)
- Internal (Lead) Auditor: VDA 6.1, ISO TS 16 949
- TQM Assessor (TÜV Rheinland)
- Certification training as QM Representative for Industry and Services (TÜV Rheinland)
- Safety engineer (Occupational safety specialist)
- Environmental assessor/Environmental auditor to ISO 14001
- Aircraft technician (Final qualification of IHK (Chamber of Industry and Commerce, Hamburg)
Professional experience
- Freelance consultant and trainer, Interim Manager as from 2001
- Divisional Manager, TÜV Akademie Rheinland (01.99 - 12.2000)
- Freelance consultant and trainer 1994-1998
- Project and departmental manager for various Consulting Engineers for process and environmental technology
Management experience (Project and Line)
- Executive and management strengths
- Systematic approach
- Management experience
Knowledge of procedures in the automotive industry
- Start-up management (Advance quality planning gem. APQP, PPAP, PPF, DoA, DoE,QFD)
- Process optimisation/transfer (workplace design, component handling, releases/Q Gates, tools, process flow, Poka Yoke, Kanban, Kaizen, goods reception, Procedures/work instructions, trouble shooting, inspection cards/assessments, management of inspection, measuring and test equipment, validation, qualification, Six Sigma, traceability, production control plans, preventive maintenance, SPC, MSA)
- Product management/databases (qualification, trials, changes, initial samples, reliability, product safety)
- SAP-/CAQ-applications
- Risk management (Ishikawa, system, design, process FMEAs)
- Audit management (Int. audit planning and implementation VDA, ISO/TS)
- Supplier management/supplier development (optimisation of quality of goods delivered, supplier audits, Pareto analyses, component management/releases)
- Customer and service management (8-D reporting, customer audit/assessment management, e.g.: Volkswagen Formel Q, General Motors GQTS/GM1927, SPICE software)
- Management system development and maintenance (VDA6.x, ISO/TS 16949)
- Change management (processes and products, parts history, releases)
- TQM-/KVP/PDCA processes
- Project management
- Quality cost management
- Claim Management
Knowledge of procedures relating to medical devices
- Medical product requirements in the USA acc. 21 CRF 820,cGMP
- FDA conformity and FDA audits
- DIN EN ISO 13485:2003
- Process validation/Qualification
- Risk analyses
Automotive projects 2002-2004 (selection)
Consulting
Audit services Int. Lead Auditor ISO/TS 16949 Transporter Development (OEM):
- Design series management
- Engineering/Design and production planning
- Product engineering
- Development
- Development controlling and support
- Vehicle systems
- TrialsPre-development/electrical and gas-driven vehicles
Service - Q-Tools
Supplier development and management (OEM):
- Implementation of supplier audits
- Business process analysis and optimisation
- Change management
- Supplier training and consulting
- "Global Quality Tracking Systems"
- "APQP, PPAP"
- "FMEA"
- "Production control planning/Control-Plan"
- "D part management/audits""Project management"
Project management "Machine and process qualification" (Tier I)
Process qualification
Period: 2 years (2002/2003)
Investment: Approx. 5 million Euro
Task:
Faster implementation of innovative processes in manufacturing. Through trial qualification in development to industrialisation and production. Use of statistical characteristic values (cmk, cpk). Creation of guidelines for "Innovation management".
Result:
Shortening of time up to production of approx. 30%
Interim-Management Quality management (Tier I, II)
Quality Manager
Period: 1 year (2004/2005), 15 members of staff
Task:
All tasks associated with quality management (Q preplanning, qualification, customer service, supplier management etc.)
management
Medical Device Projects 2002 (selection)
Consulting
Audit services for manufacturers of medical products
- Medical product requirements in the USA to 21 CRF 820,cGMP
- FDA conformity and FDA audits
- DIN EN ISO 13485:2003
- Process validation/Qualification
- Risk analyses
Interim Management Project management "process and software qualification"
Process qualification
Period: 2 years (2002)
Investment: Approx. 50 million Euro
Task:
Project management: validation/qualification of production processes, laboratories, auditing/software assessments.
Result:
Shortening of process validation by one half after takeover of the project. Achievement of FDA product license.
References (selection)
- Adam Opel AG, Entwicklung & Training, Rüsselsheim
- Adam Opel AG, ITDC, Rüsselsheim
- ALPS Electric Europa GmbH, Unterschleißheim
- Altenkirchener Kunststoff GmbH, Altenkirchen
- Aluma GmbH, Fridolfing
- Benteler KG, Paderborn
- Beru AG, Ludwigsburg
- Beru Electronics GmbH, Plochingen
- c.a.r.s. GmbH, Frankfurt
- Ceramtec AG, Plochingen
- Daimler Chrysler AG, ET, Untertürkheim
- Daimler Chrysler AG, LKW, UT
- Daimler Chrysler AG, ET/KV-KEN, Mannheim
- Delignit - Blomberger Holzindustrie B. Hausmann GmbH & Co. KG, Blomberg
- Ecka Granules GmbH & Co. KG, Fürth, Velden und Trautenfurth
- Ecka Granules Poudmet S.A.S., F-Senecourt
- ELMOS AG, Dortmund
- Faurecia GmbH, Scheuerfeld
- Faurecia GmbH, Wörth
- Gebr. Knipprath GmbH & Co., Velbert
- HEYER Medical AG, Bad Ems
- HORIBA Europe GmbH, Sulzbach
- HEAD GmbH, Ostfildern
- HELLA Saturnus, Ljubiljana, Slovenia
- IBERIS GmbH, Darmstadt
- IBS-Brocke GmbH & Co. KG
- ISE INTEX GmbH
- INA Schaeffler KG, Herzogenaurach
- LEW Automotive GmbH, Urbach
- Mepura, A-Ranshofen
- non ferrum GmbH, A-St. Georgen
- TÜV Akademie Rheinland GmbH, Köln, Mainz
- TÜV Management Systems GmbH, Köln
- CeramTec Geschäftsbereich Medizintechnik
- DELTASELECT GmbH
- HEYER Medical AG
- OHST Medizintechnik AG
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