Volker Rank - Interim Manager / Validation Project Manager / Medical Technology / In Vitro Diagnostic

Q: Where is Volker based?

Volker is based in Tuttlingen, Germany and can operate in on-site , hybrid , and remote work models.

Q: What languages does Volker speak?

Volker speaks the following languages: German (Advanced), English (Advanced) .

Q: How many years of experience does Volker have?

Volker has at least 22 years of experience. During this time, Volker has worked in at least 8 different roles and for 8 different companies . The average length of individual experience is 1 year and 5 months . Note that Volker may not have shared all experience and actually has more experience.

Q: What is Volker's latest experience?

Volker's most recent position is Interim Manager / Validation Project Manager at Medical Technology .

Q: What companies has Volker worked for in recent years?

In recent years, Volker has worked for Medical Technology , Automotive / Medical Technology , Medical Technology / Pharmaceutical Industry , Medical Technology / In Vitro Diagnostic , and Medizintechnik .

Q: Which industries is Volker most experienced in?

Volker is most experienced in industries like Professional Services , Healthcare , and Manufacturing . Volker also has some experience in Pharmaceutical .

Q: Which business areas is Volker most experienced in?

Volker is most experienced in business areas like Quality Assurance , Production , and Operations . Volker also has some experience in Strategy , Project Management , and Product Development .

Q: Which industries has Volker worked in recently?

Volker has recently worked in industries like Professional Services , Healthcare , and Manufacturing .

Q: Which business areas has Volker worked in recently?

Volker has recently worked in business areas like Operations , Strategy , and Quality Assurance .

Recommended expert

Tuttlingen, Germany

Check rate

Experience

Apr 2026 - Present

2 months

Landshut, Germany

Interim Manager / Validation Project Manager

Medical Technology

Creation of medical templates according to ISO 13485:2016 and GMP / MDR.
Design Qualification (DQ).
Validation plan (VP).
Creation of PFMEA / FMEA.
Installation Qualification (IQ).
Operational Qualification (OQ).
Performance Qualification (PQ).
Final report (AB).

Aug 2025 - Feb 2026

7 months

Ansbach, Germany

Validation Specialist / Project Management

Automotive / Medical Technology

Transition from automotive area to medical health.
Creation of qualification documents for cleanrooms ISO 7, ISO 8.
Creation and development of validation templates.
Creation of validation master plans (VMPS).
Creation of SOP for cleanrooms according to ISO 14644.
Creation of SOP for cleanroom maintenance.
Qualification templates according to ISO 13485:2016 and GMP / MDR.
Qualification of cleanrooms ISO 7, ISO 8.
Installation Qualification (IQ).
Operational Qualification (OQ).
Performance Qualification (PQ).
Final report (AB).
Test reports.
Qualification plan / qualification report.
Employee training.
Creation of work instructions (Work Standards / SOP).

Jan 2025 - Aug 2025

8 months

Hamburg, Germany

Manufacturing Engineer

Medical Technology

Qualification of laser welding machines for endoscopes.
Creation and development of validation templates.
Qualification templates according to ISO 13485:2016 and GMP / MDR.
Validation plan (VP).
Validation assessment (VA).
Installation Qualification (IQ).
Operational Qualification (OQ).
Performance Qualification (PQ).
Final report (AB).
Test reports.
Qualification plan / qualification report.
Employee training.
Creation of work instructions (Work Standards / SOP).
Complaint handling / CAPA.

Jul 2024 - Dec 2024

6 months

Tuttlingen, Germany

Manufacturing Engineer

Medical Technology

Creation and development of validation templates.
Qualification templates according to ISO 13485:2016 and GMP / MDR.
Qualification / validation of 2D matrix verifier.
Validation plan (VP).
Validation assessment (VA).
Installation Qualification (IQ).
Operational Qualification (OQ).
Performance Qualification (PQ).
Final report (AB).
Test reports.
Qualification plan / qualification report.
Employee training.
Creation of work instructions (Work Standards / SOP).
Complaint handling / CAPA.
Creation and development of NCR.
Creation and development of DCR.

Apr 2024 - Jul 2024

4 months

Landshut, Germany

Interim Manager / Validation Project Manager

Medical Technology

Creation of medical templates according to ISO 13485:2016 and GMP / MDR.
Design Qualification (DQ).
Validation plan (VP).
Creation of PFMEA / FMEA.
Installation Qualification (IQ).
Operational Qualification (OQ).
Performance Qualification (PQ).
Final report (AB).

Nov 2023 - Mar 2024

5 months

Raisting, Germany

Manufacturing Engineer

Medical Technology

Qualification of machines and validation of production processes for the manufacture of implants.
Creation of medical templates according to ISO 13485:2016 and GMP/MDR.
Validation plan (VP).
Design Qualification (DQ).
Installation Qualification (IQ).
Operational Qualification (OQ).
Performance Qualification (PQ).
Final report (AB).
Cleanroom ISO Class 7 + ISO Class 8 / dose mapping.
Creation of SOPs for various manufacturing processes.
Special approvals (assessment and tracking).
Supplier qualification / supplier evaluation.

Apr 2023 - Sep 2023

6 months

Munich, Germany

Manufacturing Engineer

Medical Technology / Pharmaceutical Industry

Qualification of feeding systems (syringe feeding) for the pharmaceutical industry.
Creation of templates according to GMP/GDP.
Creation and development of the following qualification documents:
Design Qualification (DQ).
Creation of PFMEA / FMEA.
Installation Qualification (IQ).
Operational Qualification (OQ).
Creation of Factory Acceptance Tests (FAT).
Creation of Site Acceptance Tests (SAT).
Review of requirements during acceptance of the system at the end customer.
Execution of the SAT test of the feeding system / pharmaceutical industry.

Apr 2023 - May 2023

2 months

Landshut, Germany

Interim Manager / Validation Project Manager

Medical Technology

Creation of medical templates according to ISO 13485:2016 and GMP/MDR.
Design Qualification (DQ).
Validation plan (VP).
Creation of PFMEA / FMEA.
Installation Qualification (IQ).
Operational Qualification (OQ).
Performance Qualification (PQ).
Final report (AB).

Nov 2022 - Mar 2023

5 months

Tuttlingen, Germany

Manufacturing Engineer

Medical Technology

Qualification/validation of manufacturing processes and qualification of production equipment for endoscopes, validation of bonding processes.
Creation and development of validation templates/qualification templates according to ISO 13485:2016 and GMP/MDR.
Qualification/validation of sterilizers.
Validation plan (VP).
Installation Qualification (IQ).
Operational Qualification (OQ).
Performance Qualification (PQ).
Final report (AB).
Creation and processing of test reports.
Qualification plan / qualification report.
Training of employees.
Preparation of work instructions (work standards/SOP).
Complaint handling / CAPA.

May 2022 - Nov 2022

7 months

Basel, Switzerland

Quality Engineering Specialist

Medical Technology / In Vitro Diagnostic

Qualification/validation of manufacturing processes and qualification of production equipment for blood gas analyzers/sensors (diagnostic).
Review of existing qualifications/validations for completeness/scope according to MDR.
Creation and development of validation templates/qualification templates according to ISO 13485:2016 and GMP/MDR.
Validation plan (VP).
Design Qualification (DQ).
Installation Qualification (IQ).
Operational Qualification (OQ).
Performance Qualification (PQ).
Final report (AB).
Requirements specification (LH).
Functional specification (PH).
Training of employees.
Packaging validation of sterile packaging/unsterile packaging according to DIN EN ISO 11607-1:2020 / DIN EN ISO 11607-2:2020.
Sample preparation for visual and destructive testing (seal seam strength).
Quantitative tests (verification of seal seam width, seal seam strength).
Optical inspection (bubbles, faults, wrinkles, kinks, deformities, burn-off phenomena).
Creep-to-burst test (pressure test).
Dye penetration test according to ASTM F1929.

May 2021 - May 2022

1 year 1 month

Stuttgart, Germany

Validation Project Manager

Medizintechnik

Qualification / validation of manufacturing processes and qualification of production equipment for intraocular lenses (eye implants).
Creation and development of validation templates / qualification templates according to ISO 13485:2016, GMP / MDR.
Master Validation Plan (MVP).
Failure Mode and Effects Analysis (FMEA, PFMEA).
Validation Plan (VP).
Design Qualification (DQ).
Installation Qualification (IQ).
Operational Qualification (OQ).
Performance Qualification (PQ).
Final Report (FR).
User requirements specification (URS).
Functional specification (FS).
Training of employees.
Qualification / validation of special processes (injection molding, dose mapping, ...).
Cleanroom ISO Class 7 & 8 / dose mapping.
Transport validation of blister packaging.
Packaging validation of sterile and non-sterile packaging according to DIN EN ISO 11607-1:2020 / DIN EN ISO 11607-2:2020.
Sample preparation for visual and destructive tests (seal seam strength).
Measurement tests (checking seal seam width, seal seam strength).
Visual inspection (bubbles, defects, wrinkles, kinks, deformities, burn and melt-through effects).
Creep-to-burst test (pressure test).
Dye penetration test according to ASTM F1929.
Weld validation (laser welding) including tensile test (destructive test).
Qualification / validation of steam sterilizers.
Complaint handling / CAPA.
Creation of work instructions / templates.
Change Control.
Computer software validation (CSV).

May 2021 - Oct 2021

6 months

Ulm, Germany

Manufacturing Engineer

Medizintechnik

Qualification of a thermoforming packaging machine.
Creation and development of validation templates / qualification templates according to ISO 13485:2016 and GMP / MDR.
Design Qualification (DQ).
Validation Plan (VP).
Installation Qualification (IQ).
Operational Qualification (OQ).
Performance Qualification (PQ).
Final Report (FR).
Test reports.
Traceability Matrix.
Qualification Plan (QP) / Qualification Report (QR).
Training of employees.
Creation of work instructions (work standards / SOPs).
Review of completed validations for completeness.
Validation / qualification of special processes.
Project coordination in design transfer.
Setting up change controls for product implementation.
Packaging validation of sterile and non-sterile packaging according to DIN EN ISO 11607-1:2020 / DIN EN ISO 11607-2:2020.
Sample preparation for visual and destructive tests (seal seam strength).
Measurement tests (checking seal seam width, seal seam strength).
Visual inspection (bubbles, defects, wrinkles, kinks, deformities, burn and melt-through effects).

Jan 2019 - Present

7 years 5 months

Tuttlingen, Germany

Founder / Managing Director / Interim Manager

Rank GmbH

Jan 2010 - Apr 2021

11 years 4 months

Interim Manager / Validation Specialist, Manufacturing Engineer

Diverse KMU Medizintechnik / In Vitro Diagnostic

Validation / qualification of the following products.
Dialysis machines, ophthalmology devices, radiation therapy systems (cancer therapy).
Heart-lung machines, power tools (adhesive validation).
Implantology.

Jan 2010 - Dec 2018

9 years

Kolbingen, Germany

Founder / Managing Director / Interim Manager

Vortec-Consulting

May 2004 - Dec 2009

5 years 8 months

Kolbingen, Germany

Validation / QA Technician / QA - Manager

Industry Experience

See where this freelancer has spent most of their professional time.

Experienced in Professional Services, Healthcare, Manufacturing, and Pharmaceutical.

Professional Services

Healthcare

Manufacturing

Pharmaceutical

Business Area Experience

See which departments and functions this freelancer has contributed to most.

Experienced in Quality Assurance, Production, Operations, Strategy, Project Management, and Product Development.

Quality Assurance

Production

Operations

Strategy

Project Management

Product Development

Skills

It**
Windows 10, 11
Pps / Erp System
Qsys
Syncos
Issos
Sap
Agile
Automotive
Complaint Management (Capa / 8d)
Measurement And Testing Technology
Supplier Management
Creation Of Initial Sample Inspection Reports (Ppap)
Creation And Execution Of Machine Capability Studies (Mfu)
Creation And Execution Of Process Capability Studies (Pfu)
Creation Of Measurement System Analyses (Msa)
Knowledge Of The Following Standards**
Iso 13485:2016
Iso 13485:2021-12
Din En Iso 14971
Din Iso 9001
Din En Iso 11607-1:2020-05
Din En Iso 11607-2:2020-05
21 Cfr Part 11
Iso 14644
Din En 17141:2021-02
Eu Mdr 101
Din En Iso 11607-1: 2020
Din En Iso 11607-2: 2020
Din En Iso 4063
Creation, Drafting And Execution Of:**
Mvp Master Validation Plan
Vp Validation Plan
Pfmea Process Failure Mode And Effects Analysis
Fmea Failure Mode And Effects Analysis
Urs User Requirement Specification
Dq Design Qualification
Fs Functional Specification
Tm Traceability Matrix
Fat Factory Acceptance Test
Sat Site Acceptance Test
Iq Installation Qualification
Oq Operational Qualification
Pq Performance Qualification
Ab Final Report
Lh Requirements Specification
Ph Functional Specification
Msa Measurement System Analyses
Capa Corrective And Preventive Actions
Cc Change Control (Change Management)
Csv Computer Software Validation
Ecr Engineering Change Request
Dcr Design Change Request
Dco Design Change Order
Sop Standard Operating Procedure
Tmv Test Methods Validation
Packaging Validations
Cleanroom Validations (Iso 7, Iso 8)
Cleaning Validations (Mkw, Toc)
Special Validations (Dose Mapping / Transport Validation / Adhesive Validation...)
Machinery And Equipment Qualification / Validation Of Manufacturing Processes
Project Team Leadership
Complaint Handling (Complaint Management)
Project Coordination In Design Transfer
Establishing Change Controls For Product Implementation
Process Development Of Assembly And Packaging Technologies
Creation Of Test Methods / Test Method Validation
Change Control (Change Management)
Project Management
Supplier Management

Languages

German

Advanced

English

Advanced

Education

Mar 2000 - May 2003

Technical School in Heidelberg

State-certified technician · Mechanical Engineering Technician · Heidelberg, Germany

Sep 1986 - Mar 1990

Schako KG

Apprenticeship · Mechanic, Stamping and Forming Technology · Kolbingen, Germany

Certifications & licenses

CSV validation training (in-house training)

Medical Technology Stuttgart

Guidance for Industry - FDA Process Validation (General Principles and Practices)

PTS in Fulda

Computer software validation training (CSV)

TÜV SÜD Academy GmbH in Frankfurt am Main

Guidance for Industry - FDA Process Validation (General Principles and Practices)

PTS in Fulda

Guidance for Industry - FDA Process Validation (General Principles and Practices)

PTS in Fulda

SolidWorks 2007 basic course

BBT in Tuttlingen

Quality management - methods and tools - Block Q / QA

Chamber of Industry and Commerce (IHK) in Villingen

Statistical methods for product and process monitoring - Block Q / QA

Chamber of Industry and Commerce (IHK) in Villingen

Basic course quality management - Block Q / QA

Chamber of Industry and Commerce (IHK) in Villingen

Statistics

Experience

Total positions 16

Experience in Professional Services 16.5 y

Avg length 2 y 5 m

Longest experience 11 y 3 m

Global Experience

Countries worked in 2 (Germany, Switzerland)

Primary country Germany

Expertise

Recent roles Interim Manager / Validation Project Manager, Validation Specialist / Project Management, Manufacturing Engineer

Main industries Professional Services, Healthcare, Manufacturing

Main business areas Quality Assurance, Production, Operations

Qualifications

Certifications earned 9

Profile

Created

May 2026

Need a freelancer? Find your match in seconds.

Try FRATCH GPT

Frequently asked questions

Have questions? Find more information here.

Where is Volker based?

Volker is based in Tuttlingen, Germany and can operate in on-site, hybrid, and remote work models.

What languages does Volker speak?

Volker speaks the following languages: German (Advanced), English (Advanced).

How many years of experience does Volker have?

Volker has at least 22 years of experience. During this time, Volker has worked in at least 8 different roles and for 8 different companies. The average length of individual experience is 1 year and 5 months. Note that Volker may not have shared all experience and actually has more experience.

What roles would Volker be best suited for?

Based on recent experience, Volker would be well-suited for roles such as: Interim Manager / Validation Project Manager, Validation Specialist / Project Management, Manufacturing Engineer.

What is Volker's latest experience?

Volker's most recent position is Interim Manager / Validation Project Manager at Medical Technology.

What companies has Volker worked for in recent years?

In recent years, Volker has worked for Medical Technology, Automotive / Medical Technology, Medical Technology / Pharmaceutical Industry, Medical Technology / In Vitro Diagnostic, and Medizintechnik.

Which industries is Volker most experienced in?

Volker is most experienced in industries like Professional Services, Healthcare, and Manufacturing. Volker also has some experience in Pharmaceutical.

Which business areas is Volker most experienced in?

Volker is most experienced in business areas like Quality Assurance, Production, and Operations. Volker also has some experience in Strategy, Project Management, and Product Development.

Which industries has Volker worked in recently?

Volker has recently worked in industries like Professional Services, Healthcare, and Manufacturing.

Which business areas has Volker worked in recently?

Volker has recently worked in business areas like Operations, Strategy, and Quality Assurance.

What is Volker's education?

Volker attended Technical School in Heidelberg for Mechanical Engineering Technician.

Does Volker have any certificates?

Volker has 9 certificates. Among them, these include: CSV validation training (in-house training), Guidance for Industry - FDA Process Validation (General Principles and Practices), and Computer software validation training (CSV).

What is the availability of Volker?

Volker will be available full-time from June 2026.

What is the rate of Volker?

Volker's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.