Olaf H.
Lead Auditor ISO 13485:2016 Training Course
Experience
Apr 2020 - Present
5 years 5 monthsQuality & 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 yearsQuality 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 monthsHead 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 monthQuality 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 monthsMaterials-/ Welding Engineer
Siemens AG/ Energy
- Welding Supervision
- Inspections and Audits at Suppliers
- Expert for Bearing Materials
May 1997 - Jan 2002
4 years 9 monthsWelding 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 monthsDiploma Student
Dünnschicht- und Oberflächentechnik GmbH
- Investigations on reactive deposition of wear-reducing coatings
Sep 1993 - Feb 1994
6 monthsWork Experience Student
Nordtest Prüfgesellschaft mbH
- Comparative investigations of the corrosion behavior of ship propeller bronzes
Summary
- I have over 30 years of experience in the development, implementation and maintenance of quality management systems. This includes not only ISO 13485 but also ISO 9001. As head of a quality department and QMB I was directly responsible for implementing and maintaining QMS for many years.
- Since 2023 I have been working in a project, among other things, to consider global corporate requirements in the concerns of an acquired company.
- As a certified auditor (ISO 13485) I am happy to share my knowledge and have trained internal auditors and conducted customer audits with this background.
- Document and change management are essential prerequisites for my daily work.
Languages
German
NativeEnglish
AdvancedRussian
ElementaryEducation
Sep 1990 - Mar 1996
University Halle
Diploma Engineer · Material Science · Halle (Saale), Germany · 1,7
Sep 1977 - Jul 1989
Polytechnical and Extended School
Abitur / university entrance · Rostock, Germany · 2,0
Certifications & licenses
Six Sigma Green Belt
AuditEvolution (Auditor refresher training)
AuditEvolution
Lead Auditor (ISO 13485)
NDT- Methods VT/ MT/ PT Level 2 (DIN EN ISO 9712)
Medical Device Consultant
Moderator for Design Reviews
Auditor (ISO 9001/ ISO 14001/ OHSAS 18001)
Technical Project Lead
Leadership Seminar
Quality Auditor (ISO 9001)
Siemens AG/ Energy
NDT- Methods MT/ PT Level 3 (DIN EN 473)
Quality Management Officer
Siemens AG/ Energy
Introduction to ASME Codes
International Welding Engineer (IWE)
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