ISO 9001 Experts in Zurich
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Meet FRATCH Experts in Zurich, who have recently used ISO 9001
Károly A.
Last position:
NIS2 & Risk Strategy Consultant at RRC power solutions GmbH
- Developed a compliant information security management system (ISMS)
- Advanced a modern risk management framework based on NIST for NIS2 compliance
Jürgen S.
Last position:
Manager Manufacturing Operations USP at Thermo Fisher Scientific
- Liquida, aseptic/sterile, fill & finish, solida in production & packaging
- CAPEX/Greenfield, 5kL SUT Owner, CVQ, runs/SCM/SCORE, SFM, KPI, CAD, CQV, MSAT, trainings, audits, EHS
- Organization, construction, sterile production, operations, packaging, PPQ, Op-readiness, RM, audits, documentation authoring
Hans S.
Last position:
Interim Manager, Consultant, Facilitator at Business Excellence Services GmbH
Interim manager, consultant, facilitator
Project management with focus on trouble shooting & customer care and/or product development/reengineering; regulatory management
Supply chain; risk and quality management; people management
Experienced within medical device; aerospace; packaging; small- & large equipment; optical- & electrical-systems; metal & plastics; free auditor
Since 2016, working for various accredited organizations as a freelance auditor regarding systems according to ISO 13485 and ISO 9001
2023-2024: Medical device product development, supply-chain and regulatory set-up with regard to a medical device re-engineering/launch and manufacturing
2023-2024: Project trouble shooter & customer care in the European aerospace industry within precision optics systems manufacturing; project risk and validation management including software validation
2022: Validation (FMEA, IQ OQ, PQ) management assigned with design and process risk assessment of complex electrical (IEC60601-1) mechatronics robots for MDR approval following ISO 14971
2022: Interim head of QM in aluminum-foil deep drawing process improvement; people and international Nespresso supplier quality management
2021-2022: Cytiva Cell Therapy greenfield project; assigned with design and implementation support of a certification, validation, GMP commissioning strategy for the technical infrastructure, e.g., clean rooms
2020-2021: Interim QA-Leader in Denmark assigned with the software release, manufacturing and distribution of Class IIb laser equipment for Candela, including international notified body and manufacturing transfer project
2020: Quality support and interim quality management for a manufacturer in the IVD test equipment supply chain and dialysis supplies in Bavaria
2018-2020: Expert/SME in Q-Management/Q-Engineering for orthopedic and arthroplasty device and tool production: turning, milling, cleaning, surface treatment and sterile packaging
2017: Re-engineering of the Medela product development process regarding cGMP 21CFR820.30/ISO 13485:2016 and MDR design control requirements for soft and hardware design regarding Class IIb pumps
2017: MDSAP preparation support and mock-audit coaching
2016: Interim senior QE-Expert for Maquet extracorporeal circulation devices manufacturing as ISO 14971 risk and change management expert in a Roche CAPA remediation and compliance project of IVD blood analyzers/gas sensor production
2016-2017: Orthopedic and arthroplasty implants design history file (DHF) review regarding compliance to 21 CFR 820.30 design control requirements
2015: Assigned by Novartis with design control for a new parenteral drug delivery system; manufacturability assessments during design evaluation; assessing potential plastic injection molding and/or high-volume assembly contractors in Europe and the US
2014: Assessing/auditing metallurgy process validation (IQ/OQ/PQ) of Zimmer contract manufacturers around Europe for FDA audit readiness; Depuy-Synthes subject matter expert (SME)
2013-2014: CAPA-8D process reengineering and setting in place/training new EtQ software tools; coaching of project and product managers in working through individual CAPAs; remediation of global legacy CAPAs; supporting complaint and field action (FSCA) management
2012-2013: QA/RA Manager at Sias AG for in vitro diagnostics (IVD) liquid handling robots manufacturing; led small team for electrical safety CE/CB scheme product approvals; QMS, change and CAPA management
2011-2012: Site Quality Manager at Medtronic for drug eluting balloon and Nitinol stent-catheter manufacturing; quality operations including Q-engineering and control; led 15 direct and indirect reports
2009-2010: Supported quality initiatives in medical device industry; assessments and audits for manufacturers and suppliers as a consultant of Business Excellence Services
Andrew L.
Last position:
Service Manager - Testing at Takeda Pharmaceutical International AG
- Managing the Testing services for the Global IT Testing Centre of Excellence (TCoE) team, which is responsible for managing and supporting the Product & Project Testing Workstreams on various Regional Projects, especially in Pharmacovigilance, Digital Supply Chain, Clinical Practice and R&D, etc.
- Managing Client relationships, escalations and continuing to grow the project services globally, while also driving the testing efforts on Takeda’s AI, DevOps, Agile, and Digital projects.
- Led the implementation of a Quality Management System (QMS), ensuring compliance with GCP, GMP, and Swiss and EU regulations, resulting in a huge improvement in audit readiness.
- Overseeing projects for systems including ERP, EDGE, SAP ECC, SAP Transportation Management, S/4 HANA migration etc.
- Led an AI/ML PoC for AI implementation.
- Led a cross-functional team to ensure compliance with MDR, FDA regulatory guidelines and achieved successful project deliveries.
- Led and managed change management and communication for TCoE, keeping the Takeda organisation informed of change communication and practices, including presentations to various stakeholders.
- Ensuring TCoE outsource vendor resources adhere to regulatory, compliance and quality system standards and practices for GxP & non-GxP System Development Life Cycle (SDLC) including aSDLC and TCoE Global Standards.
- Translated the product vision, strategy and requirements into backlog items, which were prioritised based on potential business impact and customer value.
Martin A.
Last position:
Martin Aicher
Main areas of activity ⋅ Martin Aicher
Areas of expertise
Medical technology
Sensor technology
Technical optics
Mechatronics
Microsystems technology
Biocompatible materials
Implants and endoprosthetics
Project management
Quality management IPMA
Regulatory affairs
Education
Dr.-Ing. Medical Technology
M.Sc. Medical Technology
Dipl. Ing. (FH) Medical Technology
Surgical mechanic, precision mechanic
Methodical product development
26 years of research, development, verification and agile product development
5 years of hands-on manufacturing of micromechanical instruments and implants
Projects
Development and verification of technical optics
Microscopy
Endoscopy
Immersion optical systems
Optical sensors
Light guides
Device development — medical electronics, active medical devices
Electromagnetic therapy devices for microcirculation of blood vessels
Electric drives, precision mechanics motors
Embedded devices, Medicine 4.0 / Industry 4.0
Feasibility studies, prototype design, electromechanical, chemical and hydrodynamic characterization up to series maturity
Structural integration of motors for pump systems
Integration of motors for catheter drives
Implantable drive systems with motors
Bone saws with Maxon motors
Osteosynthesis implant (bone implant) with linear drive
Electromagnetic therapy devices for microcirculation of blood vessels
Gold and platinum substitution for electrodes
Electrochemical impedance spectroscopy (EIS)
Characterization and development of battery cells and Li-ion batteries
Biocompatible materials: stainless steel, titanium, nitinol, polymers, ceramics, composites
Vacuum device with pumps for wound healing
Braided tubes (reinforced hoses)
Shaft instruments and trocars
Surgical instruments, minimally invasive instruments (MIC)
Analytical instruments, sensors and fluid preparation
Monitoring systems
In vivo diagnostics (IVD)
Inline measurement systems for monitoring and analytical devices
Feasibility studies, prototype design, electrochemical and hydrodynamic characterization up to series maturity
Electrochemical deionization (EDI) as a monitor
Membrane technology
Measurement method and control of carbide saturation in cooling water
pH sensor
Optical sensors with laser diodes and LEDs
Dissolved O2 sensor
CO2 sensors
Ion-selective sensor (ISE)
Conductivity sensors
Turbidity sensor according to ISO 7027
Biosensors
Flow and pressure sensors
Gold and platinum substitution for electrodes
Electrochemical impedance spectroscopy (EIS)
Biocompatible materials: stainless steel, titanium, nitinol, polymers, ceramics, composites
Design of plastic injection-molded components and housings
Calculation and design of fluid channels
Design of metal die-cast components
Design of sheet metal parts
Implants and prostheses
Endoprosthetics: knee and hip endoprostheses
Bypass implants
Nitinol stents
Bone plates
Dental implants
Precision meshes
Instruments for medical technology
Angioplasty: PTCA percutaneous transluminal coronary angioplasty with balloon catheter
Catheter system as minimally invasive heart pump
EN ISO 10555-4: intravascular catheters
Braided tubes (reinforced hoses through precision meshes)
Thrombectomy with rotablation catheter
Trocars
Surgical instruments, minimally invasive instruments (MIC)
Endoscopes ISO 8600-1, EN 60601-2-18, EN 62471
Regulatory affairs for medical devices
CE for Europe (Class II and III), EU Medical Device Regulation 2017/745 (MDR)
EU Regulation 2017/746 for in vitro diagnostics (IVDR)
Ensuring complete documentation according to current regulatory requirements
FDA registration and approval 510(k), PMN, PMA, Class II, III
Design History Files (DHF), Device Master Record (DMR), Device History Record (DHR)
Internal and external audits
FDA and CE audits
Mock audits
Requirement engineering, user requirement specifications, functional requirement specifications
Quality management and relevant standards for medical technology
EN ISO 9001:2015
EN ISO 13485:2021
USA FDA 21 CFR 820 Quality Management System
FDA 21 CFR §§ 803, 806, 807, 830
In vitro diagnostics (IVD, IVDR) FDA 21 CFR §§ 600, 610, 660
USA FDA risk management for medical devices DIN EN ISO 14971:2019
P-FMEA for production
Usability of medical devices EN 62366-1:2021
CAPA (Corrective and preventive action) and GMP
Medical electrical equipment EN 60601-1:2013
EMC for medical devices DIN EN 60601-1-2:2022
Medical device software EN 62304:2018
Cell culture in cleanroom with different cell lines for biocompatibility testing of polymers and alloys
Biological evaluation of medical devices EN ISO 10993
Clinical investigation of medical devices ISO 14155
Manufacturing technology and processes
Process qualification and validation
Injection molding technology
CNC micromechanical manufacturing
Microsystems technology, printed circuit boards (PCB)
Joining technologies: laser welding of titanium, stainless steel, plastics as well as gluing and ultrasonic welding
Evaluation, setup and qualification of equipment
Thin film and surface technology
Coating of implants and tribological surfaces with chemical vapor deposition (CVD) and physical vapor deposition (PVD), sputtering of precious metals, stainless steels, nitinol, titanium alloys, polymers and ceramics
Plasma technology for functional coatings: hydrophilic and hydrophobic surfaces
Nanotechnology: surface functionalization: self-assembled monolayers (SAM)
Product Life Cycle Management
Finite element method
ANSYS FEM
Structural mechanics, statics
Fluid mechanics, flow simulations
Electrical engineering, electromagnetic fields
Characterization and testing of microelectronics
PCB (printed circuit board)
Sensor technology
Microcontrollers
CAN bus: ISO 11898, SAE
Control and data management with LabVIEW and Matlab
Programming language
Python 3.14
CAD
Autodesk Inventor
Pro/ENGINEER, PTC Creo Parametric
SolidWorks
Siemens NX
Solid Edge
Standards-compliant technical drawings
Endurance tests, mechanical, fluid mechanical, electrical and chemical characterization
Verification, V-Model, End of Line (EOL) testing
Writing work instructions for production, English regulatory documents and scientific articles
Support of clinical studies
Data processing, digital data management and statistics
Professional handling of Microsoft Office applications: PowerPoint, Word and macro programming for Excel
© 2026 M. Aicher
Steven H.
Last position:
Mechatronics Technician (Apprentice) and Gearbox Assembly Technician at Daimler AG
- Completed apprenticeship as a mechatronics technician at Daimler AG
- Worked in gearbox assembly
- Gained experience in maintenance, manufacturing and logistics
Discover over 15,000 top freelancers
Statistics of experts using ISO 9001
Aggregated from the professional profiles of matched freelancers.
Experience
20 years
Position duration
2.8 years
Positions per freelancer
9
Top business areas
Quality Assurance, Project Management, Information Technology
Top industries
Healthcare, Biotechnology, Energy
Certification focus areas
Information Technology, Legal, Quality Assurance
Bachelor's degree or higher
83%
Master's degree or higher
67%
Doctorate
33%
Certifications per freelancer
5
Most common languages
German, English, French
Speak two or more languages
100%
Based on our profile pool as of 29 Oct 2026.
Daily rate distribution
The chart shows how the daily rates of experts in this technology in Zurich are distributed, based on recent contracts on our platform. Each bar covers a rate range — its height shows the share of experts charging within that range.
Average rates of experts in Zurich using ISO 9001
Rates are based on recent contracts and do not include FRATCH margin.
The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.
Calculated based on our freelancers’ daily rates as of 29 Oct 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
ISO 9001 experts industry focus
See which industries our matched freelancers work in most often — every figure is calculated live from the freelancers on FRATCH.
- Healthcare (67%)
- Biotechnology (50%)
- Energy (50%)
- Banking and Finance (50%)
- Insurance (50%)
- Manufacturing (50%)
- Pharmaceutical (33%)
- Telecommunication (33%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
Quality framework
ISO 9001 is the internationally recognized standard for quality management systems. It helps organizations define reliable processes, meet customer and regulatory expectations, and improve performance through a structured cycle of planning, delivery, review, and corrective action. The standard applies across manufacturing, services, healthcare, technology, and public organizations.
Certification scope
A quality management system must match the organization’s activities, products, services, and operating context. Specialists clarify the certification scope, map interested parties, assess risks and opportunities, and connect business objectives with measurable quality controls. They also help teams prepare evidence that an external certification body can review.
Core deliverables
- Quality policy, objectives, and process maps
- Document and record control procedures
- Risk, opportunity, and compliance registers
- Internal audit plans and management review inputs
- Corrective action and continual improvement workflows
These deliverables turn ISO 9001 from a set of documents into a working management system. Good specialists keep procedures usable for the people who follow them every day.
Tools and skills
ISO 9001 work often connects with process mapping, audit management, document management, enterprise risk, and business process improvement. Professionals may work with tools such as Microsoft SharePoint, Confluence, Jira, specialized quality management software, and controlled template libraries. They need strong interviewing, writing, audit, and stakeholder communication skills.
When to hire
- A new certification project needs a practical implementation plan
- An existing system has audit findings or inconsistent records
- Processes have changed after growth, restructuring, or a new product
- Internal teams need audit preparation or temporary quality expertise
Companies often bring in freelance specialists when they need focused support without adding a permanent quality function. In Zurich, remote collaboration can work well for documentation and analysis, while workshops, site reviews, and audit preparation may benefit from on-site work.
Strong specialists
Strong ISO 9001 professionals translate requirements into clear responsibilities, evidence, and routines. They understand the difference between a compliant document set and a system that improves daily operations. Look for experience with the organization’s industry, certification scope, audit findings, and chosen documentation tools, along with the ability to train teams and leave ownership behind.
Frequently asked questions
Key details about ISO 9001, drawn from the questions we get asked most.
ISO 9001 is used to establish, operate, and continually improve a quality management system. It gives organizations a consistent way to manage processes, customer requirements, risks, records, audits, and corrective actions. Certification can provide independent confirmation that the system meets the standard.
ISO 9001 is a general quality management standard that can be applied across many industries. Standards such as ISO 13485, IATF 16949, or AS9100 add requirements for specific sectors, while Lean and Six Sigma focus more on process improvement methods. The right choice depends on the organization’s products, customers, and regulatory obligations.
A strong ISO 9001 specialist often brings internal auditing, process mapping, risk management, document control, corrective action, and staff training skills. Knowledge of regulated industries, supplier quality, data protection, or environmental management can also be valuable when these topics overlap with the quality system.
The right level of ISO 9001 experience depends on the scope, maturity, and complexity of the organization. A focused document review may need a different profile from a full implementation across multiple sites or business units. Ask candidates to explain comparable certification, audit, and improvement work rather than relying only on credentials.
Much of ISO 9001 work can be completed remotely, including interviews, process analysis, document review, training, and audit preparation. On-site sessions are useful for observing operations, validating process evidence, and working with teams in Zurich or other locations. Agree in advance on access, workshops, language, and site visits.
Ask an ISO 9001 specialist to show how they have translated requirements into practical processes, records, and measurable improvements. Strong professionals ask about business risks before proposing templates, distinguish evidence from unnecessary paperwork, and explain how they will transfer knowledge to internal teams.
An ISO 9001 freelancer should begin by confirming the certification scope, organizational context, current processes, risks, and existing evidence. The first deliverables commonly include a gap assessment, prioritized action plan, responsibility map, and realistic schedule. This creates a clear basis for implementation instead of starting with generic procedures.
For ISO 9001 work in Zurich, consider the specialist’s experience with the local organization’s industry, customer expectations, and preferred working language. Clarify whether the assignment requires on-site workshops, remote documentation, or support during an external audit. The professional should communicate clearly with management and the teams who own each process.
The average hourly rate of freelancers in Zurich, Switzerland who have used ISO 9001 in their recent projects is 123 €, which corresponds to a daily rate of about 984 € based on an 8-hour working day.
Of the freelancers in Zurich, Switzerland who have used ISO 9001 in their recent projects, 83% hold at least a Bachelor's degree, 67% hold at least a Master's degree, and 33% hold a doctorate.
On average, freelancers in Zurich, Switzerland who have used ISO 9001 in their recent projects have 20 years of professional experience, with a single engagement typically lasting around 2.8 years.
The most common languages among freelancers in Zurich, Switzerland who have used ISO 9001 in their recent projects are German (100%), English (100%), and French (33%).
The most common industries among freelancers in Zurich, Switzerland who have used ISO 9001 in their recent projects are Healthcare (67%), Biotechnology (50%), and Energy (50%).
The most common business areas among freelancers in Zurich, Switzerland who have used ISO 9001 in their recent projects are Quality Assurance (100%), Project Management (67%), and Information Technology (50%).
Main locations of FRATCH Experts, who have recently used ISO 9001
Our freelancers and interim experts are at home across the DACH region — available on-site in the major business hubs or fully remote. Choose a location to discover matched specialists, local market insights and up-to-date availability.
Countries:
Zurich 
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