Volker R.-Interim Manager / Validation Project Manager / Medical Technology / In Vitro Diagnostic
Check rate
Experience
Interim Manager / Validation Project Manager
Medical Technology
- Preparation of medical templates according to ISO 13485:2016 and GMP / MDR.
- Design Qualification (DQ).
- Validation Plan (VP).
- Preparation of PFMEA / FMEA.
- Installation Qualification (IQ).
- Operational Qualification (OQ).
- Performance Qualification (PQ).
- Final Report (AB).
Validation Specialist / Validation Specialist / Project Management
Automotive / Medical Technology
- Transition from the Automotive sector to Medical Health.
- Preparation of qualification documents for ISO 7 and ISO 8 cleanrooms.
- Preparation and development of validation templates.
- Preparation of validation master plans VMPs.
- Preparation of SOPs for cleanrooms according to ISO 14644.
- Preparation of SOPs for cleanroom maintenance.
- Qualification templates according to ISO 13485:2016 and GMP / MDR.
- Qualification of ISO 7 and ISO 8 cleanrooms.
- Installation Qualification (IQ).
- Operational Qualification (OQ).
- Performance Qualification (PQ).
- Final Report (AB).
- Test reports.
- Qualification plan / qualification report.
- Employee training.
- Preparation of work instructions (Work Standards / SOP).
Manufacturing Engineer / Manufacturing Engineer
Medical Technology
- Qualification of laser welding machines for Eoscopes.
- Preparation 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.
- Preparation of work instructions (Work Standards / SOP).
- Complaint processing / CAPA.
Manufacturing Engineer / Manufacturing Engineer
Medical Technology
- Preparation 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.
- Preparation of work instructions (Work Standards / SOP).
- Complaint processing / CAPA.
- Preparation and development of NCRs.
- Preparation and development of DCRs.
Interim Manager / Validation Project Manager
Medical Technology
- Preparation of medical templates according to ISO 13485:2016 and GMP / MDR.
- Design Qualification (DQ).
- Validation Plan (VP).
- Preparation of PFMEA / FMEA.
- Installation Qualification (IQ).
- Operational Qualification (OQ).
- Performance Qualification (PQ).
- Final Report (AB).
Manufacturing Engineer / 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 releases (evaluation and follow-up).
- Supplier qualification / supplier evaluation.
Manufacturing Engineer / 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 preparation of the following qualification documents:
- Design Qualification (DQ).
- Preparation of PFMEA / FMEA.
- Installation Qualification (IQ).
- Operational Qualification (OQ).
- Creation of Factory Acceptance Tests (FAT).
- Creation of Side Acceptance Tests (SAT).
- Review of the requirements when accepting the system at the end customer’s site.
- Execution of the SAT test of the feeding system / pharmaceutical industry.
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).
- Preparation of PFMEA / FMEA.
- Installation Qualification (IQ).
- Operational Qualification (OQ).
- Performance Qualification (PQ).
- Final Report (AB).
Manufacturing Engineer / Manufacturing Engineer
Medical Technology
- Qualification / validation of manufacturing processes and qualification of production equipment for endoscopes, validation of bonding processes.
- Creation and preparation 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.
- Employee training.
- Creation of work instructions (Work Standards / SOP).
- Complaint handling / CAPA.
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 preparation 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).
- User Requirement Specification (LH).
- Functional Specification (PH).
- Employee training.
- Packaging validation of sterile packaging / non-sterile packaging according to DIN EN ISO 11607 - 1: 2020 / DIN EN ISO 11607-2: 2020.
- Sample preparation for visual and destructive testing (seal strength).
- Measured testing (checking seal width, seal strength).
- Visual inspection (blistering, defects, wrinkles, creases, deformations, burn-through and melting effects).
- Creep to burst Test (pressure test).
- Dye Penetration Test according to ASTM F 1929.
Validation Project Manager
Medical Technology
- Qualification / validation of manufacturing processes and qualification of production equipment for intraocular lenses (eye implants).
- Creation and development of validation templates / qualification templates in accordance with 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 (AB).
- User Requirements Specification (LH).
- Functional Requirements Specification (PH).
- Employee training.
- 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 packaging / non-sterile packaging in accordance with DIN EN ISO 11607 - 1: 2020 / DIN EN ISO 11607-2: 2020.
- Sample preparation for visual and destructive testing (seal strength).
- Measurement-based testing (checking seal width, seal strength).
- Visual inspection (bubble formation, defects, folds, creases, deformations, burn-melting effects).
- Creep to burst Test (pressure test).
- Dye Penetration Test in accordance with ASTM F 1929.
- Welding validation (laser welding) including tensile test (destructive testing).
- Qualification / validation of steam sterilizers.
- Complaint handling / CAPA.
- Creation of work instructions / templates.
- Change Control.
- Computer Software Validation (CSV).
Manufacturing Engineer
Medical Technology
- Qualification of a thermoforming packaging machine.
- Creation and development of validation templates / qualification templates in accordance with ISO 13485:2016 and GMP / MDR.
- Design Qualification (DQ).
- Validation Plan (VP).
- Installation Qualification (IQ).
- Operational Qualification (OQ).
- Performance Qualification (PQ).
- Final Report (AB).
- Test reports.
- Traceability Matrix.
- Qualification Plan (QP) / Qualification Report (QB).
- Employee training.
- Creation of work instructions (Work Standards / SOP).
- Review of completed validations for completeness.
- Validation / qualification of special processes.
- Project coordination in the Design Transfer area.
- Implementation of change controls for product implementation.
- Packaging validation of sterile packaging / non-sterile packaging in accordance with DIN EN ISO 11607 - 1: 2020 / DIN EN ISO 11607-2: 2020.
- Sample preparation for visual and destructive testing (seal strength).
- Measurement-based testing (checking seal width, seal strength).
- Visual inspection (bubble formation, defects, folds, creases, deformations, burn-melting effects).
Founder / Managing Director / Interim Manager
RANK GmbH
Interim Manager / Validation Specialist, Manufacturing Engineer
Various SMEs in Medical Technology / In Vitro Diagnostic
- Validation / qualification of the following products.
- Dialysis equipment, ophthalmology, irradiation systems (cancer therapy).
- Heart-lung machines, Power Tools (adhesive validation).
- Implantology.
Founder / Managing Director / Interim Manager
Vortec-Consulting
AV / 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.
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.
Skills
It**
Windows 10, 11
Pps / Erp System
Qsys
Syncos
Issos
Sap
Agile
Automotive
Complaint Management (Capa / 8 D)
Measurement And Testing Technology
Supplier Management
Preparation Of Initial Sample Inspection Reports (Ppap)
Preparation And Performance Of Machine Capability Studies (Mfu)
Preparation And Performance Of Process Capability Studies (Pfu)
Preparation 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
Preparation, Development 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 User Requirements Specification
Ph Functional Requirements Specification
Msa Measurement System Analyses
Capa Corrective And Preventive Action
Cc Change Control (Change Management)
Csv Computer Software Validation
Ecr Engineering Change Request
Dcr Design Change Request
Dco Design Change Order
Sop Standard Operation Procedure
Tmv Test Method Validation
Packaging Validations
Cleanroom Validations (Iso 7,Iso 8)
Cleaning Validations (Mkw, Toc)
Special Validation (Dose Mapping / Transport Validation / Adhesive Validation...)
Machine And Equipment Qualification / Validation Of Manufacturing Processes
Management Of Project Teams
Complaint Processing (Compliant Management)
Project Coordination In The Design Transfer Area
Establishment Of Change Controls For Product Implementation
Process Development For Assembly And Packaging Technologies
Preparation Of Test Methods / Test Method Validation
Change Control (Change Management)
Project Management
Supplier Management
Languages
Education
Technikerschule In Heidelberg
Staatlich geprüfter Techniker · Maschinenbautechniker · Heidelberg, Germany
Schako KG
Ausbildung · Mechaniker, Stanz Und Umformtechnik · Kolbingen, Germany
Certifications & licenses
Schulung Csv-Validierung (Inhouse-Schulung)
Medizintechnik Stuttgart
Guidiance For Industry Der Fda Prozess Validation (General Principles And Practices)
Firma PTS in Fulda
Schulung Computer Software Validierung (Csv)
TÜV SÜD Akademie GmbH in Frankfurt am Main
Guidiance For Industry Der Fda Prozess Validation (General Principles And Practices)
Firma PTS in Fulda
Guidiance For Industry Der Fda Prozess Validation (General Principles And Practices)
Firma PTS in Fulda
Solid Works 2007 Grundkurs
BBT in Tuttlingen
Qualitätsmanagement - Methoden und Werkzeuge - Block Q / QA
IHK in Villingen
Statistische Methoden zur Produkt und Prozessüberwachung Block Q / QA
Industrie und Handelskammer (IHK) in Villingen
Grundlehrgang Qualitätsmanagement Block Q / QA
Industrie und Handelskammer (IHK) in Villingen
Statistics
Experience
Global experience
Expertise
Qualifications
Frequently asked questions
Have questions? Find more information here.
Volker is based in Tuttlingen, Germany and can operate in on-site, hybrid, and remote work models.
Volker speaks the following languages: German (Advanced), English (Advanced).
Volker has at least 23 years of experience. During this time, Volker has worked in at least 9 different roles and for 7 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.
Based on recent experience, Volker would be well-suited for roles such as: Interim Manager / Validation Project Manager, Validation Specialist / Validation Specialist / Project Management, Manufacturing Engineer / Manufacturing Engineer.
Volker's most recent position is Interim Manager / Validation Project Manager at Medical Technology.
In recent years, Volker has worked for Medical Technology, Automotive / Medical Technology, Medical Technology / Pharmaceutical Industry, Medical Technology / In Vitro Diagnostic, and RANK GmbH.
Volker is most experienced in industries like Professional Services, Healthcare, and Manufacturing. Volker also has some experience in Pharmaceutical.
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.
Volker has recently worked in industries like Professional Services, Healthcare, and Manufacturing.
Volker has recently worked in business areas like Operations, Strategy, and Quality Assurance.
Volker attended Technikerschule In Heidelberg for Maschinenbautechniker.
Volker has 9 certificates. Among them, these include: Schulung Csv-Validierung (Inhouse-Schulung), Guidiance For Industry Der Fda Prozess Validation (General Principles And Practices), and Schulung Computer Software Validierung (Csv).
Volker is immediately available full-time for suitable projects.
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Average rates for similar positions
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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 5 Nov 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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