Olaf Herrmann - Lead Auditor ISO 13485:2016 Training Course | FRATCH

en
de

Selm, Germany

Experience

Apr 2020 - Present

5 years 10 months

Quality & Regulatory Affairs Manager (freelance)

QuSmed Herrmann

Quality assurance for cardiological applications, CAPA remediation, risk management/ FMEA (parts cleaning) and supplier quality management
Supplier qualification and audits (ISO 13485) as well as first article inspection, SCAR process
Quality management for surgical robotics components incl. risk management, FMEA (soldering, crimping, adhesive, assembly) and process validation, Non Conformity and CAPA process
RA management for surgical robotics components
Product certification according to (EU) VO 2017/745 for surgically invasive instruments, class IIa/b

Apr 2018 - Mar 2020

2 years

Quality Manager

Stapleline Medizintechnik GmbH

Quality management & Regulatory Affairs
Development- Project management
Audits (ISO 13485) at suppliers and internally

Feb 2016 - Sep 2019

3 years 8 months

Head of Quality

Bomafa Armaturen GmbH/ Special Valves

Responsible for 3 employees
Quality Management Officer
CE- Representative
Audits/ inspections at suppliers and internally

Jan 2015 - Jan 2016

1 year 1 month

Quality Engineer (for Hays GmbH)

MHPSE GmbH/ Power Systems

Quality Control of Suppliers
Documentation Review
Checking and Meeting Requirements of Regulations

Feb 2002 - May 2014

12 years 4 months

Materials-/ Welding Engineer

Siemens AG/ Energy

Welding Supervision
Inspections and Audits at Suppliers
Expert for Bearing Materials

May 1997 - Jan 2002

4 years 9 months

Welding Engineer and Site Manager

Dahmen KG/ Piping

Welding and Site Supervision
Issuance of Quality Documentation
Issuance of a Welding Quality Management Handbook (DIN EN 729/ ISO 3834-2)

Apr 1995 - Dec 1995

9 months

Diploma Student

Dünnschicht- und Oberflächentechnik GmbH

Investigations on reactive deposition of wear-reducing coatings

Sep 1993 - Feb 1994

6 months

Work Experience Student

Nordtest Prüfgesellschaft mbH

Comparative investigations of the corrosion behavior of ship propeller bronzes

Languages

German

Native

English

Advanced

Russian

Elementary

Certifications & licenses

Lead Auditor ISO 13485:2016 Training Course

BSI

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