
Olaf H. Nitz
Suchst Du einen anderen Olaf H. Nitz?
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Olaf H. Nitz
- Bis heute 6 Jahre und 2 Monate, seit Apr. 2019
Deputy General Manager
CODAN ARGUS AG
- Bis heute 7 Jahre, seit Juni 2018
Head of Quality Assurance & Regulatory Affairs
CODAN ARGUS AG
- Bis heute 7 Jahre und 2 Monate, seit Apr. 2018TÜV SÜD Akademie GmbH
Referent / Course Instructor / Trainer
- 5 Monate, Jan. 2018 - Mai 2018
Director Quality Assurance & Regulatory Affairs
Miracor Medical SA, Awans, Belgium
• Member of the Executive Management Team • 3 direct reports and management of intra disciplinary in-/external project teams • Maintaining the QMS in accordance with ISO 13485 & FDA 21 QSR 820 (MDR / ISO 13485:2016) • Change Management in accordance with 93/42 EEC • CAPA Management • Leading Supplier Audits • Elaboration the Regulatory Strategy for the US-Market (IDE/PMA) • Submission and execution of IDE Presub-meetings • Compilation and submission of technical files; Class IIb and III (cardiology)
- 5 Jahre und 1 Monat, Jan. 2013 - Jan. 2018
Director Quality Assurance & Regulatory Affairs
Miracor Medical Systems GmbH, Vienna, Austria
includes the above as well • Integration of Software Development as core competency and the adoption of ISO 62304 • Risk management in accordance with ISO 14971 • Clinical Affairs support in: o Formulation and adoption of the clinical procedure to use “PiCSO” as an adjunct therapy for acute myocardial infarct patients o Preparation and conduction of clinical and experimental studies in the EU and CANADA (GLP) o SIV o User Trainings and Clinical Application
- 4 Jahre und 4 Monate, Sep. 2008 - Dez. 2012
Director Quality Assurance & Regulatory Affairs
Miracor Medical Systems GmbH, Baar, Switzerland
includes the above as well • Creation of Product labels • Technical writing of IFU’s and User Manuals • CE-marking of novel medical devices in accordance with 93/42 EEC device Class IIb and III (cardiology) • Successful certification of an entire new QM-System under ISO 13485 with in 14 months • Project Management in the development of a novel Medical Devices (PiCSO) for patients suffering Acute Myocardial Infarction (AMI, STEMI). Consisting of an 8F catheter and a control unit (PiCSO)
- 2 Jahre und 3 Monate, Mai 2006 - Juli 2008
Marketing & Sales
bfa solutions ltd
• Product Management for Software solutions for optimisation and traceability of production processes in industrial areas • Project Management of provided solutions for production processes and lines/machines in different branches (automotive, medical) • Leadership of project teams of 3 to 5 members • Acquisition (CH, EU) • Key Account Management (CH, EU)
- 1 Jahr, Mai 2005 - Apr. 2006
Market Development / Product Manager CMF
Synthes GmbH
- 4 Jahre und 4 Monate, Jan. 2001 - Apr. 2005
Key Account Manager
Auparc AG
- Market responsibility in Medical Technology and clusters in Medical Technology - Management of customer related outsourcing projects - Professional guidance of 5 employees - Management of a reorganisation project (Electronic Manufacturing), - Analysis/Development/implementation of operational and organisational structure
- 10 Monate, März 2000 - Dez. 2000
Betriebsleiter
Femit Plastic AG
- Planning and coordination of PET-Bottle-Production including logistics - Dispatching of 3 and 4 shift operation - Supervision of 8 permanent employees - Member of the Q-Management team, responsible for inspection equipment (ISO 9000) - Project management of several customised projects and core project member for implementation of new ERP-System
- 8 Jahre und 8 Monate, Juli 1991 - Feb. 2000
Production Engineer
Mettler Toledo GmbH
- Development and optimisation of new processes and preparation for a future automation - Advisory service for Research and Development in manufacturing/assembly engineering - Professional guidance of 8 employees- Setup of the assembly line after the production transfer from the US - Short term assignment at OHAUS Corp., Florham Park NJ (USA), an affiliate of Mettler Toledo GmbH - Preparation of production- and process transfer to Switzerland, including a Clean room, FS-Class 10’000 (ISO 7)
Ausbildung von Olaf H. Nitz
- 2 Jahre, Jan. 2007 - Dez. 2008
Ausbildung ohne Abschluss
GSBA Zürich
Dipl. Betriebstechniker TS
ITA Zürich
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
XING Mitglieder mit ähnlichen Profilangaben
XING – Das Jobs-Netzwerk
Über eine Million Jobs
Entdecke mit XING genau den Job, der wirklich zu Dir passt.
Persönliche Job-Angebote
Lass Dich finden von Arbeitgebern und über 20.000 Recruiter·innen.
22 Mio. Mitglieder
Knüpf neue Kontakte und erhalte Impulse für ein besseres Job-Leben.
Kostenlos profitieren
Schon als Basis-Mitglied kannst Du Deine Job-Suche deutlich optimieren.