Oliver Friedli

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

-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)

-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

-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

-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.

-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

-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

-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