Expert in quality, delivery and process management in the … · 2021. 6. 9. · Karin E....
Transcript of Expert in quality, delivery and process management in the … · 2021. 6. 9. · Karin E....
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
Expert in quality, delivery and process management in the
automotive and pharma industries
As an expert in quality, supplier and process management in the automotive, pharmaceutical and
cosmetics industries, I take over the project management or interim management of divisions and
departments. My clients benefit not only from my experience in managing a large number of
successful projects, but also from my extensive technical expertise, my understanding of methods,
and knowledge of engineering standards.
My service is especially valuable such as when troubleshooting topics need to be moderated or de-
escalation skills are required. This is what enables me to insure a project’s success. My customers are
usually medium-sized companies, family businesses or group units that are internationally positioned.
MY SERVICES AS INTERIM MANAGER OR PROJECT MANAGER
QUALITY MANAGEMENT DELIVERY MANAGEMENT PROCESS MANAGEMENT
• Implementation of standards and regulations, including GxP conformity
• Analysis, coordination and implementation of customer specifications in business processes, organization and products
• Stakeholder management • Internal and external
industry standard audits • Organize CIP using a
PDCA cycle • Troubleshooting with
customers (de-escalation)
• As APQP, successfully integrating the core tools for the customer/supplier
• Supplier qualification • SQA = check and secure
suppliers and products • Implement supplier
evaluation systems internally and externally
• Troubleshooting with suppliers (de-escalation)
• Map and organize production processes in the ERP system
• Develop and coordinate interfaces
• Develop, analyze and implement production processes, as well as validate and qualify (FAT, SAT) incl. DQ, OQ, IQ, PQ
• Integration of standards, product specifications, commercial aspects and quality requirements
Karin E. Bogenreuther
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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MY CUSTOMERS AND BRANCHES
Most of my customers are mid-sized companies, family run businesses or corporate businesses,
acting in the international market.
Automobile interior / exterior (OEM, tier 1-3),
Pharma (primary packaging/ production plants)
Cosmetics (primary packaging/ production plants)
WHAT SETS ME APART ...
• extensive technical and methodological knowledge
• knowledge of relevant standards
• skills in moderating and de-escalation for goal oriented resolutions
• strong implementation skills as well as ability to quickly comprehend complicated procedures
• goal and success oriented work structure
• pronounced social competence and empathy
• as a versitalist, flexibly deployable in a wide-range of positions
WHAT MY COLLEAGUES SAY ABOUT ME ...
Head of Quality Management - ad interim, BRUSA Elektronik AG (on behalf of QAS-Company AG)
“Karin Bogenreuther took over the management of the project professionally and consistently had it under control. We would use her services again at any time for a comparable project. "
Alexander Blab
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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OVERVIEW OF MY PROJECTS AS INTERIM MANAGER
Reference projects in the automotive industry (OEM, tier 1 – 3)
Brusa Elektronik AG Schweiz Interim position: Head of Quality Management
VALEO Klimasysteme GmbH Quality Project Team Member
KS - Kunststoff Schwanden AG APQP for Power Train Module
Delvis products GmbH Senior Process Planner for lights package 5-set
HBPO GmbH APQP for flagship project assembly cockpit Porsche Tycan
Autolive B.V.&Co. KG Werk Süd APQP for airbag development
BMW headrest and side airbag and Mercedes driver’s airbag
HBPO GmbH APQP for flagship assembly center console AUDI Q5
Hella KG Hueck & Co.
Process Planner: LED single and multifunction lights, car tag lighting for (VW, Audi)
Porsche AG Purchasable Components Quality Planner/ Launching Manager of Purchasable Components Porsche Cayenne NF (E2)
Hella KG Hueck & Co. Process Planner: LED single purpose lights (Turn signal SAAB, AUDI)
QIC Systemverbund Managing Director: Project Manager - Diverse Automotive Projects
Manfred Jacob Kunststofftechnik GmbH
Project Manager – Foil inserts for insert molding
Reference projects in the pharma and cosmetics industries (primary packaging)
SCHOTT Schweiz AG Product Engineer „Ready-to-use packaging“ for syringe systems and glass vials
SCHOTT Schweiz AG Product Design Engineer for syringe systems
WEST Pharmaceutical Service Deutschland GmbH & Co. KG
Project consultant pharma development capping system = „LyoSeal“
NEOPAC AG Head of Quality Management
Beauty Pack Design und Technik GmbH i.G.
Interim Manager - Technical Director
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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Reference projects in the automotive industry (OEM, TIER 1 – 3)
Brusa Elektronik AG Schweiz Energy efficient
Vacancy gap: Head of Quality Management
Branch: • Automotive: tier 1+2 • E-Mobility
Sales figures: • 40M CHF Number of employees: • 160 employees in Switzerland Situation: • Vacant position: Head of Quality Management
Location: • Switzerland
Sennwald und Heerbrugg SG
Internet: • www.brusa.biz
Duration: 11/2019 to 04/2020
Scope of Responsibility (Budget / Employees): • 1 Mio. CHF • 3 external freelancers plus 1 employee until 12/2019)
Assignment: • managing quality department • re-certification ISO 9001/2015 • project support and integration of diverse international norms
(IATF 16949, TISAX/ISO 27001, ASpice/ISO 26262, ISO 14001 and ISO 45001)
• analyzing customer specifications
Measures: • Development and management of an efficient QM department • Head Count 2020 and for new projects • implementation of Core Tools in all internal/external projects
Achievements: • successful re-certification ISO 9001/2015 • maintaining an efficient QM department incl. implementation of
norms and customer specifications
Special Challenges: • lacking structure in the QM department • management of 3 freelancers plus 1 employee until 12/2019 • transfer of knowledge regarding quality requirements in the
automotive industry (OEM and tier 1-2) of management
VALEO Klimasysteme GmbH Thermal Front End Module
Quality Project Team Member (QPTM) Front End Modul Mercedes C-Class
Branch: • Automotive: tier 1+2
Sales figures: • 4.7B worldwide
Number of employees: • approx. 115,000 worldwide
Situation: • No internal qualified personnel
available
Location: • Im Projekt- Werk Bremen
Internet: • www.valeo.de
Duration: 07/2019 to 10/2019
Area of responsibility (budget / employees): N / A
Job description:
• Responsibility for quality in the Front End Assembly C-Class project
• SOP coordination in the Bremen plant
• Internal / external quality coordination
Measures:
• Supporting coordination for the start of the SOP
• "End of line" camera system and process inspection concepts
• Internal / external communication
Achievements:
• Successful start of SOP
• Implementation of the "end of line" camera system concept and in process and test concepts including measuring systems
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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Special challenges:
• Very time-sensitive
• Replacement of in-house production Mercedes
• No defined customer specifications • Production systems not coordinated with Q requirements
KS Kunststoff Schwanden AG Innovative Plastic Solutions
APQO for power training module
Branch: • Automotive: tier 1-3
Sales figures: • 4.7B worldwide
Number of employees: • approx. 500
Situation: • shortage of personnel in der Q
department
Sitz: • Switzerland, Schwanden GL
Internet: • www.ks-ag.ch
Duration: 09/2018 to 02/2019
Area of responsibility (budget / employees): N / A
Job description:
• Quality advance planning (APQP) for power training modules for the VW Group and Mercedes
• Implementation of teaching and measurement concepts
Measures:
• Quality support (PLP, FMEA, EMBP etc.) in the projects including maintenance of the customer portals (One, Convisint)
• Benchmark of measuring equipment suppliers and measuring service providers
Achievements:
• Coordinated customer-supplier requirements
• Expansion of the Q processes including the use of core tools
Special challenges:
• Very time sensitive
• Replacement of in-house production Mercedes
• No defined customer specifications • Production systems not coordinated with Q requirements
Delvis products GmbH Intelligente Lichtsysteme
Senior Process planner for 5-set lighting package
Branch:
• Automotive: tier 1-3
Sales figures:
• N / A
Number of employees:
• 100 employees
Situation:
• Lack of professional competence
Seat:
• Germany, Regensburg
Internet: • www.delvis.de
Duration: 03/2018 to 07/2018
Area of responsibility (budget / employees): N / A
Order content:
• Production and process definition
• Supplier benchmark equipment and production partners
Measures:
• Process description including benchmark production partners
• Specifications for the equipment (including injection molding tools, production equipment and measuring systems) and request for quotations
• Benchmark with suppliers of equipment and production partners
Achievements:
• Clarity on the requirements for process and production equipment
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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Special challenges: • Unstructured company / team no clear customer specifications
• 80% of the project was staffed by freelancers
HBPO GmbH THE MODULE COMPANY
APQP for flagship project assembly of cockpit Porsche Tycan
Branch: • Automotive: tier 1+2
Sales figures: • 2B worldwide
Number of employees: • 2400 worldwide
Situation: • lack of professional expertise • Know-how transfer
Location: • Germany, Lippstadt
Internet: • www.hbpogroup.com
Duration: 06/2017 to 01/2018
Area of responsibility (budget / employees):
• N / A
Order content:
• Know-how transfer and implementation of quality and customer specifications
• Assembly, testing and measurement concepts including deriving the specification sheet
• Participation in the customer / supplier committees
Measures:
• Robust quality and assembly concept
• Close coordination with the customer and supplier committees
• Assembly, testing and measuring concepts
• Implementation of customer specifications from Formula Q Concrete
Achievements:
• First measurement concept / system at HBPO with GOM Atos 5 scanBox
• Transparent and open exchange of communication with customers and suppliers
Special challenges:
• Flagship project - first order for a cockpit module assembly
• Pre-selected suppliers (directed parts) by the customer
WHAT MY COLLEAGUES SAY ABOUT ME ...
Head Quality Management (with HV), Profitcenter Neopac
“Under the management of Ms. Bogenreuther, our company was the first primary packaging manufacturer in Switzerland to be certified according to the ISO 15378 standard“ Requirements for primary packaging for pharmaceuticals. ”
Robert Hauswirth
Operations Manager at HOFFMANN NEOPAC AG, Oberdiessbach, Switzerland
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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HBPO GmbH THE MODULE COMPANY
APQP for flagship project
Assembly of middle console AUDI Q5
Branch: • Automotive: tier 1+2
Sales figures: • 2B worldwide
Number of employees: • 2400 worldwide
Situation: • lack of professional expertise • Know-how transfer
Location: • Germany, Lippstadt
Internet: • www.hbpogroup.com
Duration 06/2015 to 04/2016
Area of responsibility (budget / employees):
• No budget responsibility
• Incorporation of 5 employees from Mexico
Order content:
• Know-how transfer and implementation of quality and customer specifications
• Implementing the pre-assembly concept for series production
• Test and measurement concepts including the derivation of the specification sheet
• Participation in the customer / supplier committees
Activities:
• Robust quality and assembly concept for series production in Mexico
• Close coordination with the customer and supplier committees
• Meisterbock support including the derivation of measures
• Assembly, testing and measuring concepts
• Implementation of customer specifications from Formula Q Concrete
Achievements:
• First measurement concept / system at HBPO with GOM Atos scanBox
• Transparent and open exchange of communication with customers and suppliers
• Problem-free start of SOP in Mexico
Special challenges:
• Flagship project - first order for a middle module assembly • Pre-selected suppliers (standard parts) by the customer
Hella KG Hueck & Co. Technologie mit Weitblick
Process planner: LED single and multi-function lamps license plate light VW / Audi
Branch: • Automotive: tier 1+2
Sales figures: • €4.4B worldwide (2012)
Number of employees: • 29,000 worldwide (2012)
Situation: • lack of personnel
Location: • Germany, Lippstadt
Internet: • www.hella.com
Duration: 01/2011 to 06/2012
LED license plate light for all vehicles from VW / Audi
Additional indicator for VW Golf 7, Audi A3, and SEAT
Order content:
• Manufacturing processes. Analyze and coordinate (injection molding, vapor deposition, VIB and US welding, assembly and joining technology, fully automated production system including packaging)
• Implement / comply with VDA 6.3 and TS 6949 standards
• Implementation of customer specifications from Formula Q Concrete
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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Measures:
• Creating robust manufacturing concept
• Manufacturing structure analysis
• Optimization of the process and the assembly concept
• Process flow, series process layout and cost assessment
• Determination of the assembly, testing and adjustment process, as well as the necessary systems and equipment and their procurement
• Definition of the required quality control loop
• Project support and implementation up to acceptance
• Coordination of the equipment (injection molding tools, welding tools and assembly systems) sampling and production (in the Hella plant in Banovce-Slovakia)
Achievements:
• Implementation of robust manufacturing concept
Special challenges:
• Quantities and time critical project
• New US welding processes, fully automated production • Production in the Hella plant in Banovce-Slovakia)
Porsche AG VW-Werk Bratislava (SVK)
Ramp-up management for purchased parts Porsche Cayenne NF (E2)
Purchased parts quality planner
Branch: • OEM - Automotive
Sales figures: • Porsche AG €9,232M
Number of employees: • Porsche AG 15,000 (2010) • VW Werk approx. 8,000 (2010)
Situation: • Project 1: lack of personnel • Project 2: my expertise
Location: • Porsche AG
• Germany, Zuffenhausen Baden Würtenberg
• VW Werk • Slovakia, Bratislava
Internet: • www.porsche.com
Duration 05/2009 to 04/2010
Area of responsibility (budget / employees):
• N / A
Order content:
• Start-up management for purchased parts for cockpit, center console, door panels and color matching
• Qualification according to VDA 6.3 and TS 16949
• Representation in the committees as part of the start of series production
Measures:
• Coordination of the vehicles in the VW factory for exercise series, special vehicles (trade fair / press), PVs and 0 series
• Accompanying the failure analysis and coordination (master jig / cubing) of the components
• Feedback of the errors including error analysis to the PAG quality planners and the suppliers
• Monitoring of the corrective measures and feedback of the initiated corrective measures in the VW plant and at the suppliers
• Monitoring / implementation of special measures (sorting actions, rework, special tests) in the factory and at suppliers
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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• Coordination with all PAG departments: development, purchasing, project management, as well as in the VW plant with production, purchasing and quality assurance
• Coordination of color matching with the specialist departments and suppliers
• Monitoring in the event of deviations and ensuring corrective measures
• Compliance with customer specifications from Formula Q Concrete
Achievements:
• Color matching fulfilled for all responsible assemblies
• Purchased part quality for the responsible assemblies according to VDA 6.3. and TS 16949 implemented
Special challenges:
• Coordination of suppliers
• Ensuring the quality of the purchased parts
Hella KG Hueck & Co. Technologie mit Weitblick
Process Planner LED single function lamps (indicator for SAAB and AUDI)
Branch: • Automotive tier 1+2
Sales figures: • €4.4B worldwide (2012)
Number of employees: • 29,000 worldwide (2012)
Situation: • Lack of personnel
Sitz: • Germany, Lippstadt
Internet: • www.hella.com
Duration: 06/2008 to 01/2010
Area of responsibility (budget / employees):
• N / A
LED auxiliary indicators Audi (A1, A3, A4, A6 and Q7)
Flashing light / dummy for SAAB
Order content:
• Analyzing and coordinating manufacturing processes (injection molding, vapor deposition, VIB welding, assembly and joining technology)
• Implementing / complying with standard specification VDA 6.3 and TS 6949
Measures:
• Robust manufacturing concept created
• Manufacturing structure analysis
• Optimization of the process and the assembly concept
• Determination of the assembly, testing and adjustment process, as well as the necessary systems and equipment and their procurement
• Definition of the required quality control loops
• Project support and implementation up to acceptance
Achievements:
• Pre-production and series production fulfilled according to specifications
• Process optimization implemented efficiently
Special challenges:
• New VIB welding processes • No experience in lighting systems
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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WHAT MY COLLEAGUES SAY ABOUT ME ...
Head of the quality department at BRUSA Elektronik AG, Sennwald (Switzerland)
“In spite of the fact that the entire quality department was manned by external staff, Ms.
Bogenreuther, in cooperation with our team, created a comprehensive concept for solving the
problems encountered in various areas. The focus was on the prioritization of tasks, team building in
the department and technical and individual support. I always found it extremely enjoyable to work
with Ms. Bogenreuther; was a pleasure working with her."
Hamed Husejnovic (Supply Quality Engineer)
Managing Director of ACQM GmbH, Berchtesgaden
QIC Systemverbund Kunststofftechnik GmbH
Managing Director Project manager - Diverse Automotive Projects
Branch:
• Automotive tier 1-3
• Association of 9 plastics processing and engineering companies
Sales figures:
• N / A
Number of employees:
• 5 employees (300 employees network)
Situation:
• Search for a manager Location: Germany, Wilhelmsdorf - Mittelfranken
Internet: • https://www.ihk-
nuernberg.de/de/IHK-Magazin-WiM/WiM-Archiv/WIM-Daten/2002-02/Unternehmen-und-Personen/Kunststoff-Pionier-fuer-den-Automobil-Leichtbau.jsp
Duration 06/1999 to 09/2001
Area of responsibility (budget / employees):
• No budget responsibility
• 5 employees
Task of managing director QIC
• Management of the GmbH, including monthly jour fixes with all 8 GF of the affiliated companies
• Management of joint training courses
• Coordinate project manager for overarching projects (at least 2-3 companies involved)
Achievements:
• Acquisition of well-known automotive OEMs for joint projects
• Establishment of the QIC nationally and internationally
Special challenges:
• Coordination of 9 affiliated companies (8 GF) with very different characteristics and business models
• Control of the overarching projects
Task of project manager "lightweight front / rear bumper systems for BMW M 3
• Coordination of the project companies - AC.S Advanced Composite Systems GmbH (semi-finished products made of thermoplastic), the engineering office com_posite consultants from Dr. Börger (engineering), Jacob Composite GmbH (joining and forming) with the customer and supplier
• Efficient team management and meetings
• Coordination with the customer BMW M
• Analysis of the FEM calculations for the organic sheet
• Weight reduction by at least 20%
• Control of development and sampling
• Implementation of the project ready for series production
Achievements:
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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• Projects prepared for series production
• Crash test completed with success
• Commercial challenge mastered (target price reached)
• Weight reduction by over 20% successfully implemented
Special challenges:
• Coordination of the companies involved, the customer and the suppliers
• Bringing new material / technology for automotive into series production and meet all requirements (weight, strength, safety, price, quality)
Autoliv B.V.&Co. KG Werk Süd Driven for life
APQP for Airbag Development BMW headrest and side airbags and Mercedes driver’s airbag
Branch: • Automotive: tier 1-3
Sales figures: • 10.4B USD worldwide (2017)
Number of Employees: • 72,000 worldwide
Situation: • lack of personnel
Location: • Germany Werk Süd
Dachau-Bayern
Internet: • www.autoliv.com
Duration 07/2016 to 02/2017
Area of responsibility (budget / employees): N / A
Order content:
• Supervise development projects as APQP
• Implementation of customer specifications and VDA 6.3 and IATF 16949
• Maintenance of the BMW portal IPQ
Measures:
• Analysis of the test features and definition of the production control plan (PLP)
• Coordination and support of the sampling including the documentation
• Error analysis and corrective measures implemented
• Implementation of core tools, standards, regulatory and customer requirements in development projects
Achievements:
• Professional contact with customers
• Internal high recognition for APQP for development projects
Special challenges:
• No experience with airbags • Customer loyalty (BMW) in the quality area
Manfred Jacob Kunststofftechnik GmbH
Project Manager – Foil inserts for insert molding
Branch: • Automotive: tier 1-3
Sales figures: • N/A
Number of Employees: • 200
Situation:
Duration 06/1999 to 09/2001
Area of responsibility (budget / employees): N / A
Projects
• Various foil insert parts BMW AG - MINI Cooper
• Foil insert for headlights (eyebrow) HELLA Renault Clio
• Various Avery Dension PT-Cruiser foil inserts
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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• Looking for double function QIC management and project manager
Location: • Germany, Wilhelmsdorf -
Mittelfranken
Internet: • www.jacob-
kunststofftechnik.de
• Special foil insert for 4-component SmithKline Beecham toothbrush
• Various integral foil parts, center console VISTION FORF Focus
• Various foil inserts from Johnson Controls Mercedes SLK and Toyota Avensis
• Foil inserts for center console and gearshift cover OHLO FORD Mondeo
• Complete project management for 3 participating companies, including the production facilities
• Efficient team management and meetings (internal / external)
• Coordination with the customer / supplier committees
• Control of development and sampling (internal / external)
• Quality specifications and compliance using APQP, PPAP, FMEA (core tools according to VDA and TS 16949)
• Coordination of resources, process planning / validation
• Implementation of the projects ready for series production
Achievements:
• Projects implemented for series production
• Supervision of the sampling (internal / external)
Special challenges:
• Coordination of the companies, customers and suppliers involved
• New material / technology for OEMs and Tier 1-3 • Bringing new material / technology into series production and
meeting all requirements (development, price, quality)
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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Reference projects in pharma and cosmetics (primary packaging)
SCHOTT Schweiz AG Glass made of ideas
Product Engineer „Ready-to-use packaging “ for syringe systems and glass vials
Branch:
• Pharmaceutical Packaging
• Syringe system
Sales figures:
• €2.2 billion worldwide
• €0.9 billion Europe
Number of employees:
• 1600 employees worldwide
• 590 employees in Switzerland
Situation:
• Skilled personnel requirement project "Ready-to-use packaging"
Location: • Switzerland, St. Gallen SG
Internet:
• www.schott.com
Duration 02/2017 to 05/2017 (employee)
Area of responsibility (budget / employees): N / A
Task:
• Project team member "Ready-to-use packaging" for product and process
• Compare product requirements to / from filling systems manufacturers and customers - benchmark
SCHOTT Schweiz AG Glass made of ideas
Product Design Engineer for syringe system
Branch: • Pharmaceutical Packaging • Syringe systems
Sales figures: • €1.87B worldwide (2013/2014)
Number of employees: • 1,540 worldwide (2013/2014) • 500 Switzerland (2013/2014)
Situation: • shortage of personnel • product engineering
Location: • Switzerland, St. Gallen SG
Internet: • www.schott.com
Duration 06/2015 to 04/2016
Area of responsibility (budget / employees):
• N / A
Order content
• Implementation of customer-specific, normative and regulatory requirements in product requirements and properties
• Documentation of the development steps according to the specifications of the development process and the pharmaceutical requirements (design control)
• Creation of risk analysis (D-FMEA) and test plans for design verification
• Optimization of components and packaging
Measures:
• Organization of the test results
• Analysis of the components and packaging, including design / material change proposals
Achievements:
• Successful completion of customer design qualifications including documentation
• Actionable design / material suggestions for components and packaging
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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Special Challenges:
• Customer-specific, normative and regulatory documentation (GMP / FDA, ISO 13485 and 21 CRF 4 following)
WEST Pharmaceutical Service Deutschland GmbH & Co. KG
Project consultant pharma development
multi-component sealing system = „LyoSeal“
Branche: • Pharmaceutical Packaging
Sales figures: • 1.4B USD worldwide
Number of employees: • 7,300 worldwide • 900 Germany
Situation: • shortage of personnel in the
project “LyoSeal“
Location: • Germany, Stolberg - Rheinland
Internet: • www.westpharma.com
Duration 05/2013 to 12/2013
Area of responsibility (budget / employees):
• N / A
Order content:
• Project team management
• Pharma-compliant material changeover for the patented “LyoSeal” multi-component sealing system
Measures:
• Analysis of the available pharmaceutical-compliant plastics with approval
• Analysis of the FEM calculation, deriving and implementing measures for this
• Elaboration of the requirement specifications, test and sampling concepts created and implemented
• Definition and coordination of samples, measurements and tests (change process)
• Compliance check
• Creation and maintenance of the design history file
Achievements:
• Sampling, testing and design qualification with new certified pharmaceutical compliant plastic
Special challenge:
• Conversion to certified pharmaceutical-compliant plastic for the patented product "LyoSeal" in compliance with the product-specific requirements
NEOPAC AG THE TUBE
Head of Quality Management
Branch: • Pharmaceutical Packaging • Primary packaging for
pharmaceuticals and cosmetics
Sales figures: • N/A
Number of employees: • 200 Switzerland
Situation: • Filling of the position Head of
Quality Management
Location: • Switzerland, Oberdiessbach BE
Duration 11/2006 to 04/2008 (employee)
Area of responsibility (employees):
• 16 employees (14 QA / QC and 2 QM assistants)
Task:
• Expansion and maintenance of the Q system according to ISO 9001/2000
• Update, maintenance and further development of the management system based on ISO 15378/2006
• Active participation in the implementation of and compliance with the requirements of GMP guidelines and the topic of "safety"
• Ensure GMP conformity in projects
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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Internet: • www.neopac.com
• Implementation and support of customers, suppliers and internal / external audits
• Organization and implementation of QA training
• Ensuring the Q tests on raw materials and purchased parts
• Intermediate and end products customer care in relation to QA issues
• Processing of complaints (customers / suppliers) and monitoring of defined corrective and preventive measures
• Ensuring cross-departmental cooperation in quality assurance
• Budget responsibility of the QM department
• Management of 14 employees in the Quality Assurance and Quality Control departments
Achievements:
• Certification ISO 15378/2006 “Requirements for primary packaging for pharmaceuticals” as the first primary packaging manufacturer in Switzerland.
• Efficient coordination of customers (cosmetics / pharmaceuticals), suppliers and standard committees
Beauty Pack Design und Technik GmbH i.G.
Interim Manager - Technical Director
Branch: • Primary packaging “cosmetics”
Sales figures: • N/A
Number of employees: • 20 worldwide
Situation: • Lack of technical expertise
Location: • Germany, Mondorf bei Bonn
Duration 10/1993 to 02/1995
Area of responsibility (budget / employees): N / A
Order content:
• Technical support sales, customers, suppliers and the branch in USA
• Benchmark for potential suppliers
• Alternative materials (plastics)
• Implementation of design in feasible products
Measures:
• Managing mascara units, lipstick, lip liner, nail polish, powder jars and other closures as primary packaging (customer Channoine), the coordination of technical drawings / requirements, quality specifications and managing supplier selection
• Coordination and know-how transfer for the joint venture in Turkey / Istanbul
• Tests on primary packaging using materials such as aluminum, thermoplastics with wood, soft touch, and highly transparent (Suryln) plastics
• Eyeliner pen systems developed and implemented with partner company
Achievements:
• Cosmetics line for the customer Channoine and in-house developments implemented
• Competent suppliers found
Special challenges:
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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• Design-savvy company
• No technical competence and no suppliers
WHAT MY COLLEAGUES SAY ABOUT ME ...
Management / Management of QIC Systemverbund Kunststofftechnik GmbH
"Due to her systematic approach and her strong ability to work in a team, Karin Bogenreuther was both
successful at creating solutions to technical problems as well as successful at dealing with commercial
issues."
Werner Gubesch, Management of QIC Systemverbund Kunststofftechnik GmbH
PERMANENT POSITIONS & INITIAL AND FURTHER EDUCATION
HOFFMANN NEOPAC AG Head Quality Management
Primary packaging for pharma and cosmetics
Duration: 11.2006-04.2008
Tasks & Topics:
• Quality management, assurance, control and system, process and supplier audits
• ISO 9001, 13 485 and 15 378, RAL 493 GZ-GMP • Clean room prod. (Class D) with DQ, IQ, OQ, PQ
QIC Systemverbund Kunststofftechnik GmbH
Directing Manager
Association of 8 plastics processing companies
Duration: 06.1999- 09.2001
Dr. Jan Rau GmbH, Saarbrücken
Department Manager for Bavaria
CAE service provider and IBM branch office
Duration: 05.1993-09.1993
Company bankruptcy
TRAFFA Tronic GmbH, Nordenberg
Product Manager/Head of Training Sales representative for CAD / CAM systems
CAE service provider and IBM branch office
Duration: 11.1990-03.1993
Company bankruptcy
geka-brush Gruppe, Bechhofen
Diverse Stations
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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Manufacturer of primary packaging for cosmetics, pharmaceuticals and technology
Duration: 08.1976-10.1990
Training as a technical draftsman in metals
Designer of molds and plastic products
Organizer for filing systems and CAE-CATIA
Project / product manager for developments
Area Sales Manager of the subsidiaries
Subsidiary. geka-brush LtD. in USA
Duration: 04.1988-04.1990
Product Development Manager, establishment of an efficient and rational development department, production and quality know-how transfer
initial and continuing education
05.2006-07.2006 DGQ Deutsche Gesellschaft f. Qualität e.V.
QM-Systems and internal auditing; QM applications
06.2000-09.2000 KESS Project management training
Project management course
10.1995-07.1996 Seminarzentrum Göttingen GmbH Academic advanced training "Assistant in the
preparation and support of Chinese business "
01.1995-04.1995 Technische Akademie Esslingen
Leadership qualification for engineers and scientists
06.1979-07.1982 Berufsschule Ansbach
Skilled worker certificate: technical draftsman for metal
09.1976-05.1979 Berufsschule Rothenburg/Bechhofen
Craft for paintbrush and brush makers
09.1967-08.1976 Grund- und Hauptschule Bechhofen
Secondary school certificate
Additional qualifications
Foreign languages Written and spoken English due to a 2-year job in the USA and various international projects in Europe and Asia
IT knowledge MS-Office, MS-Project , MS Visio, SAP R3
Diverse quality software and OEM-Portals
Other qualifications Quality, supplier, process and project management
Pharma: ISO13 485, ISO15 378, RAL493 GZ / GMP
Automotive: ISO 9100, VDA 6.3, IATF 16 949
Core tools (QVP / RGA, FMEA, MSA, SPC, PLP, PPAP / PPF, 8D, PLP, supplier qualification
Boarding school Project management, including selection of production sites and relocations
Karin E. Bogenreuther • Steinwichslenstrasse 4 • CH-9052 Niederteufen AR Natel: +41 76 / 20 58 070 • Handy: +49 176 / 41 51 38 60 [email protected] • www.Bogenreuther.ch
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Personnel management and personal development training,
Additional training for engineers in business administration
Continuous education through literature / lectures
Development, new materials, and manufacturing concepts
Aviation quality know-how through literature / lectures
Automotive, plastics and pharmaceutical industries
QM method: CIP, TQM, SWOT, etc.
External activities DSIM umbrella organization of Swiss interim managers Active member in various XING networks
Hobbies Sculptures / objects made of steel, stone and wood
classical music, foreign countries and cultures
Status: March 2021