Olaf H. Nitz Email and Phone Number
Olaf H. Nitz work email
- Valid
Olaf H. Nitz personal email
I am passionate about delivering high-quality solutions that improve patient outcomes and enhance customer satisfaction with the goal of fostering a culture of diversity and innovation. Believing that businesses have the responsibility to drive positive change in society and mitigate their environmental impact.I have successfully navigated complex business landscapes, formulated effective strategies, and implemented several process improvement and compliance initiatives in the Medical Device sector, ensuring compliance with global standards and regulations, and facilitating the development and launch of safe and effective Medical Devices. With over 20 years of experience in the medical device industry, I am a seasoned leader and expert in quality assurance, regulatory affairs, and production engineering. I hold a QM-Auditor ISO 13485 certification and have a strong background in metal- and plastics processing, electronic- and manufacturing assembly lines, and clean rooms.
Swiss Medtech
View- Website:
- swiss-medtech.ch
- Employees:
- 39
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President "Fachgruppe Aussenhandel" Swiss MedtechSwiss MedtechZurich, Switzerland
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Vice President Quality, Regulatoy & Clinical AffairsSkope Magnetic Resonance Technologies Apr 2024 - PresentZurich, Ch -
Manager Quality Assurance Regulatory AffairsCanon Medical Systems Europe Apr 2024 - PresentAmstelveen, Zuid-Holland, Nl -
Referent / Course Instructor / TrainerTüv Süd Akademie Gmbh Apr 2018 - PresentMunich, Germany, DeReferent / Course Instructor for courses with respect to Medical Devices at the TÜV SÜD Akademie (DACH) at the Academies onsite, virtual or Inhouse at Customer site (DE/EN) -
President "Fachgruppe Aussenhandel" Swiss MedtechSwiss Medtech Jun 2020 - PresentBern, Schweiz, ChEstablishment and co-presidency of a new “Fachgruppe (FG)” under the auspices of SWISS MEDTECH
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Deputy Managing DirectorCodan Argus Ag Apr 2019 - Mar 2024Baar, Zug, ChIn cooperation with the Managing Director, the establishment of the strategic alignment of the company, including planning and execution of the change management and a realigned HR strategy with the goal of culture change, increased diversity, and innovation thinking. -
Head Of Quality Assurance & Regulatory AffairsCodan Argus Ag Jun 2018 - Mar 2024Baar, Zug, ChIntroduction and Implementation of a Lean Integrated Management System ISO 13485 and FDA 21 QSR 820, including the Certification according to ISO 14001:2015 within 12 months (zero findings).Building and encouraging a diverse and specialised Team with the ability to: autonomy, authenticity, self-motivation, initiative and target oriented action, within less than two years.
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Director Quality Assurance & Regulatory AffairsMiracor Medical Sa Sep 2008 - May 2018Hognoul, Walloon Region, BeMiracor Medical Systems GmbH, Vienna Austria - (01/2013 - 01/2018)Miracor Medical Sales & Marketing GmbH, Baar Switzerland - (09/2008 - 12/2012)Member of the founding team (Executive Management Team) of a start-up for medical devices in the field of cardiology. Involved in defining and implementing the strategic direction of the company including venture capital funding rounds.Certification of a QMS to ISO 13485 from zero to certification within 12 months including alignment to FDA 21 QSR 820.Responsibility for the regulatory strategy for Europe and the US market for IDE/PMA submission with preparation and execution of clinical and experimental studies in the EU and CANADA (GLP), incl. training of clinical staff and formulation and adaptation of clinical procedures. -
Key Account Manager / Product Manager, Marketing & SalesBfa Solutions Ltd. May 2006 - Jul 2008Fällanden, Ch, ChKey Account Management and Business Development (CH, EU) for a newly developed software solution to optimise and trace production/manufacturing process parameters. Project Management during the implementation and adoption phase of the provided solutions, especially for complex production lines and standalone automation cells in different branches (e.g. automotive, medical devices). -
Market Development Manager / Product Manager Biomaterials CmfSynthes May 2005 - Apr 2006Raynham, Ma, UsMarket Development Manager / Product Manager for Bioresorbable Implants and Bone grafts and substitutes in Cranio-Maxillofacial surgery (CMF) in EMEA, LAT-AM and AP. -
Key Account ManagerCicor Group (Auparc) Jan 2001 - Apr 2005Bronschhofen, Sg, ChKey account Manager and Project Manager in contract manufacturing for medical devices Market responsibility in Europe (7 MCHF, Respiratory Devices, Incubators for Neonates, Mother-Care, Pain Therapy, …). -
Manufacturing ManagerFemit Plastik Ag Feb 2000 - Dec 2000Planning and coordination of PET-Bottle-Production including logistics, dispatch of 3 to 4 shift operations and Project management of several customised projects and core project member for implementation of new ERP-System.
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Production EngineerMettler-Toledo International, Inc Jul 1991 - Feb 2000Greifensee, ChIntroduction and further development of high-speed machining (HSC) of load cells composed of high-strength aluminum alloys (aircraft industry), including procurement of the machinery park.Short term assignment at OHAUS Corp., Florham Park NJ (USA), an affiliate of Mettler Toledo GmbH, for the preparation of a production- and process transfer to Mettler Toledo in Nänikon, including a clean room, FS-Class 10’000 (ISO 7) and Robotic cell for high resolution strain gauge load cells.
Olaf H. Nitz Skills
Olaf H. Nitz Education Details
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Tüv Süd Akademie Gmbh, München(Ec) 1221/2009 (Emas Iii) -
Tüv Süd Akademie Gmbh, MünchenQm-Auditor Iso 13485 : 2016
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Tüv Süd Akademie Gmbh, MünchenSafety Officer (§30 Mpg)
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Tüv Süd Akademie Gmbh, MünchenManager Regulatory Affairs International - Tüv
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Gsba „Graduate School Of Business Administration“, ZürichMarketing
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Gsba „Graduate School Of Business Administration“, ZürichBusiness Administration
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Swissmem, WinterthurTechnical Sales Advisor
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Ita ”Institut Für Technische Ausbildung”, ZürichBetriebstechniker Ts (Business Economist)
Frequently Asked Questions about Olaf H. Nitz
What company does Olaf H. Nitz work for?
Olaf H. Nitz works for Swiss Medtech
What is Olaf H. Nitz's role at the current company?
Olaf H. Nitz's current role is President "Fachgruppe Aussenhandel" Swiss Medtech.
What is Olaf H. Nitz's email address?
Olaf H. Nitz's email address is on****@****ewin.ch
What schools did Olaf H. Nitz attend?
Olaf H. Nitz attended Tüv Süd Akademie Gmbh, München, Tüv Süd Akademie Gmbh, München, Tüv Süd Akademie Gmbh, München, Tüv Süd Akademie Gmbh, München, Gsba „graduate School Of Business Administration“, Zürich, Gsba „graduate School Of Business Administration“, Zürich, Swissmem, Winterthur, Ita ”institut Für Technische Ausbildung”, Zürich.
What skills is Olaf H. Nitz known for?
Olaf H. Nitz has skills like Medical Devices, Iso 13485, Quality Assurance, Product Development, Start Ups, Regulatory Affairs, Cardiology, Risk Management, Iso, Clinical, Quality Systems, Quality System.
Who are Olaf H. Nitz's colleagues?
Olaf H. Nitz's colleagues are Juliette Michèle Von Arx, Claudia Guldimann, Tobias Geiser, Katrin Siebenbuerger Hacki, Kathrin Rieder, Barbara Mettler, Doris Loretan.
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