Oliver Friedli
Angestellt, Senior RA Specialist, SenTec AG
Basel, Schweiz
Werdegang
Berufserfahrung von Oliver Friedli
Bis heute 3 Jahre und 1 Monat, seit Juni 2021
Senior RA Specialist
SenTec AG
Bis heute 5 Jahre und 3 Monate, seit Apr. 2019
Manager Quality Assurance and Regulatory Affairs
CTC Diagnostics AG
Management Representative according ISO 13485 and US FDA 21 CFR 820.20(3) Responsible for the full certification by a Notified Body according ISO 13485:2016; Scope: In-Vitro Diagnostics/Blood Screening Infectious Disease/Blood Grouping Implementation of the In-Vitro Diagnostic Medical Device Regulation (EU) 2017/746
1 Jahr und 5 Monate, Nov. 2017 - März 2019
Senior Quality Engineer
Radiometer Basel AG
-CAPA process owner -Management of Supplier Quality Audits -Management of Internal Quality Audits -Supplier Management -Complaint Handling/ Vigilance -Support of audits by authorities and regulatory bodies -Quality Agreements -Quality assurance within Design Transfer projects -Quality assurance within product sustainment projects -Management and reporting of the company’s Quality KPIs -Implementation and maintenance of Statistical Methods -Statistical data analysis (Subject Matter Expert)
2 Jahre und 10 Monate, Jan. 2015 - Okt. 2017
Manager RAQA (Management Representative)
Radiometer Basel AG
-Lead the regulatory compliance and QA strategy -Quality KPIs -Lead audits by authorities -Quality Agreements -CAPA process owner -Complaint Handling -Supplier Quality Audits -Internal Quality Audits -Support of Vigilance activities -Conduct Management Reviews -Support of Product Registration -Provision of QA guidance/ approval within product sustainment -Provision of QA guidance/ approval within Design Transfer -Management of applicable standards
1 Jahr und 2 Monate, Nov. 2013 - Dez. 2014
Quality Engineer
Radiometer Basel AG
-Risk Management according to ISO 14971 -Define and improve the Product Development Process -Design controls according to US FDA QSR and ISO 13485 -Provision of QA guidance/ approval within Design Transfer projects -Support audits by authorities -Support of internal audits -Quality Agreements -Disposition of NCs -Reliability Engineering -Maintenance of the ‘Quality Management System‘ -Support of Product Registration activities (Medical Device class IIb and I)
-QA support within Product Development Projects -Risk management according to ISO 14971 -Design Verification & Design Validation -Product Deviations
6 Jahre und 7 Monate, Dez. 2001 - Juni 2008
Validation Engineer
Christ AQUA ecolife AG
-Qualification (IQ, OQ, FAT) of water purification systems for pharmaceutical applications according to current FDA / GMP guidelines -Responsible for the validation documentation -Organisation of the qualification department -Commissioning, training and customer care -EU Machinery Directive and Low Voltage Directive as well as implementation of GAMP requirements within the company.
1 Jahr und 6 Monate, Juni 2000 - Nov. 2001
Design Engineer for electromechanical systems
ABB Industrie AG
-Design of components and modules for air and water cooled medium voltage drives, meeting cost and deadline targets -Obtaining quotations and developing solutions -Implementation of design changes -Timely preparation and submission of order information and checklists, bills of materials, customer, assembly and production documents -Support of sales and product management -Production support
5 Jahre und 5 Monate, Jan. 1995 - Mai 2000
Design Engineer
Münster AG
-Project manager for customized air filtration systems -Design and development of customized air filtration systems -Creating detailed technical drawings (CAD) -Compilation of bills of material and work documents for production -Preparation of operating and maintenance instructions -Cooperation in the revision of the product range with the aim of cost reduction and production optimization
8 Monate, Mai 1993 - Dez. 1993
Project Manager (movable Pallet and cantilever high load systems)
FOCO Forster AG
-Order processing (design, planning and implementation) -Material disposition and purchasing for the assigned projects -Installation supervision -Billing
-Creating CAD workshop drawings of complex constructions of conveyor and warehouse technology
Ausbildung von Oliver Friedli
6 Jahre und 1 Monat, Jan. 2009 - Jan. 2015
History
The Open University
3 Jahre und 1 Monat, Jan. 2003 - Jan. 2006
Project Management, Strategic Management, Leadership
Kalaidos Fachhochschule Wirtschaft AG
3 Jahre und 1 Monat, Jan. 1996 - Jan. 1999
Mechanical Engineering
IBZ Schulen für Technik Informatik Wirtschaft
4 Jahre und 1 Monat, Jan. 1987 - Jan. 1991
Mechanical Engineering
Walter Stöcklin AG
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Französisch
Gut
Japanisch
Grundlagen