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Artem Davidenko-Independent Auditor / Reviewer/Consultant/QM

Artem Davidenko - Independent Auditor / Reviewer/Consultant/QM - profile avatar
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Available
Witten, Germany

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Experience

Oct 2020 - Present

Auditor / Reviewer/Consultant/QM

Self-employed

Position Summary
Auditor / Reviewer/Consultant/QM at Self-employed
Industries
Healthcare
Pharmaceutical
Business Areas
Audit
Operations
Quality Assurance
Research and Development
  • Support/development of management systems
  • Process mapping
  • Creation of quality-related documentation for ISO 9001/13485
  • Creation and delivery of training courses
  • Internal/external audits on behalf of clients/review of audits, etc.
  • Biocompatibility assessments according to 10993
  • Risk assessments according to ISO 14971
  • Preparation/support of clinical studies in cooperation with a CRO from Bulgaria
Jan 2017 - Sep 2020
Dortmund, Germany

QM Manager, Medical Device Safety Officer

Dr. Ausbüttel & Co. GmbH

Position Summary
QM Manager, Medical Device Safety Officer at Dr. Ausbüttel & Co. GmbH
Industries
Healthcare
Manufacturing
Business Areas
Operations
Product Development
Project Management
Quality Assurance
Research and Development
  • Further development of the QM system according to ISO 13485:2016
  • Internal and external audits as needed
  • Internal training on QM topics or medical device consultant topics as needed
  • Management of procedures and work instructions
  • Handling of deviations/corrective and preventive actions
  • Maintenance of technical documentation together with R&D
  • Contact with customers/medical device consultants/authorities as safety officer
  • Coordination of a clinical study
Jul 2013 - Dec 2016
Witten, Germany

QM Manager/Product Developer/Deputy Safety Officer

Dr. Ausbüttel & Co. GmbH

Position Summary
QM Manager/Product Developer/Deputy Safety Officer at Dr. Ausbüttel & Co. GmbH
Industries
Healthcare
Business Areas
Audit
Product Development
Quality Assurance
Research and Development
  • Internal and external audits (suppliers/service providers)
  • Risk management according to ISO 14971 together with R&D
  • Handling of complaints and deviations/corrective and preventive actions/initiation and monitoring of actions
  • Development of medical devices class 1 to 3, especially for rare diseases and antimicrobial products
Jan 2012 - Jun 2013
Witten, Germany

Product Developer/Medical Devices

Dr. Ausbüttel & Co. GmbH

Position Summary
Product Developer/Medical Devices at Dr. Ausbüttel & Co. GmbH
Industries
Healthcare
Manufacturing
Business Areas
Procurement
Product Development
Project Management
Quality Assurance
Research and Development
  • Development of medical devices class 1 to 3
  • Project management
  • Evaluation of suppliers/visits to suppliers
  • Assessment of laboratory results
Sep 2008 - Dec 2011
Aachen, Germany

Scientific employee/PhD candidate

DWI at RWTH

Position Summary
Scientific employee/PhD candidate at DWI at RWTH
Industries
Biotechnology
Healthcare
Business Areas
Product Development
Research and Development
  • Work on the industry project „NanoSilk" (BASF/L&R)
  • Development of an innovative wound dressing based on spider-silk-like proteins
  • Preparation of the dissertation
Oct 2001 - Mar 2002
Hanover, Germany
On-site

Academic Internship

Institute of Biochemistry/Medical School

Position Summary
Academic Internship at Institute of Biochemistry/Medical School
Industries
Education
Healthcare
Business Areas
Research and Development

Academic internship / biochemical-molecular biology laboratory

Sep 1998 - Jun 2000
Rostov-on-Don, Russian Federation
On-site

Internship

Central Laboratory 124 of the Medical-Criminal Identification of the Ministry of Defence of the Russian Federation

Position Summary
Internship at Central Laboratory 124 of the Medical-Criminal Identification of the Ministry of Defence of the Russian Federation
Industries
Aerospace and Defense
Government and Administration
Business Areas
Research and Development

Preparation of two annual papers / PCR / DNA extraction / molecular biological methods

Industry Experience

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

Experienced in Healthcare, Pharmaceutical, Manufacturing, Biotechnology, Aerospace and Defense, and Government and Administration.

Healthcare
Pharmaceutical
Manufacturing
Biotechnology
Aerospace and Defense
Government and Administration
Profile match chart

Business Area Experience

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

Experienced in Research and Development, Quality Assurance, Product Development, Audit, Operations, and Project Management.

Research and Development
Quality Assurance
Product Development
Audit
Operations
Project Management
Profile match chart

Skills

Iso 9001 Iso 13485 Iso 14971 Fmea Gmp Iso 10993 Clinical Studies

Languages

Russian
Native
German
Advanced
English
Intermediate

Education

Sep 2008 - Mar 2013

RWTH

Dr.rer.nat · Chemistry · Aachen, Germany · 1.0

Doctoral thesis in cooperation with the following companies: BASF, Freudenberg, Lohman&Raucher

Oct 2002 - Jul 2008

Leibiz University Hannover

Diploma Biochemist · Biochemistry · Hanover, Germany · 2.4

Sep 1996 - Jun 2000

State University in Rostov-on-Don

Biology · Rostov-on-Don, Russian Federation

...and 1 more

Statistics

Experience

Total positions 7
Experience in Healthcare 18.5 y
Avg length 2 y 10 m
Longest experience 5 y 10 m

Global Experience

Countries worked in 2 (Germany, Russian Federation)
Primary country Germany

Expertise

Recent roles Auditor / Reviewer/Consultant/QM, QM Manager, Medical Device Safety Officer, QM Manager/Product Developer/Deputy Safety Officer
Main industries Healthcare, Pharmaceutical, Manufacturing
Main business areas Research and Development, Quality Assurance, Product Development

Qualifications

Highest degree Doctorate

Profile

Created

Frequently asked questions

Have questions? Find more information here.

Artem is based in Witten, Germany and prefers 100% remote projects.

Artem speaks the following languages: Russian (Native), German (Advanced), English (Intermediate).

Artem has at least 20 years of experience. During this time, Artem has worked in at least 7 different roles and for 5 different companies. The average length of individual experience is 3 years and 10 months. Note that Artem may not have shared all experience and actually has more experience.

Based on recent experience, Artem would be well-suited for roles such as: Auditor / Reviewer/Consultant/QM, QM Manager, Medical Device Safety Officer, QM Manager/Product Developer/Deputy Safety Officer.

Artem's most recent position is Auditor / Reviewer/Consultant/QM at Self-employed.

In recent years, Artem has worked for Self-employed.

Artem is most experienced in industries like Healthcare, Pharmaceutical, and Manufacturing. Artem also has some experience in Biotechnology, Aerospace and Defense, and Government and Administration.

Artem is most experienced in business areas like Research and Development, Quality Assurance, and Product Development. Artem also has some experience in Operations, Audit, and Project Management.

Artem has recently worked in industries like Healthcare and Pharmaceutical.

Artem has recently worked in business areas like Audit, Operations, and Quality Assurance.

Artem holds a Doctorate in Chemistry from RWTH, a Bachelor in Biochemistry from Leibiz University Hannover and a Bachelor in Biology from State University in Rostov-on-Don.

Artem is immediately available part-time for suitable projects.

Daily Rate Distribution

0 2 4 6 8
<€640 €720-800 €800-880 €960+

The rates shown represent the typical market range for freelancers in this position based on recent contracts on our platform.

Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.

Average rates for similar positions

Rates are based on recent contracts and do not include FRATCH margin.

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Rate comparison chart
Daily rate avg. 920 €

The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.

1000
750
500
250
Rate comparison chart
Median rate 960 €

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.

Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.