Sanne Hjorth Andersen Email & Phone Number

Copenhagen, Dk

Copenhagen, Capital Region, Denmark

Quality management of medical devices and device constituent parts for combination products fromdevelopment to commercialization. Responsible for quality assurance of device R&D activities, riskmanagement, validation activities, as well as manufacturing activities and release of medical devices to the market.

Providing the organisation with guidance within risk management, design control, sterilisation, and regulatory compliance. Representing QA in cross-functional development and product maintenance projects as well as IVDR and MDR projects.

Copenhagen Area, Capital Region, Denmark

Providing the organisation with guidance within risk management, design control and regulatory compliance. Representing QA in cross-functional development and product maintenance projects. Currently part of an IVDR project.

Specialist within medical device ETO and radiation sterilisation supporting the global organisation with expert knowledge. Executing validations and re-validations activities in accordance with ISO 11137 and ISO 11135. Part of development and maintenance projects working with both internally and externally produced productsAdditional tasks:- Initiate and handle CAPAs, NCs, deviations and change requests- Managing external sterilisation suppliers: Creating quality agreements, auditing, performance monitoring, handling deviations/NCs- Creating and maintaining instructions and procedures - Manage external sterilisation suppliers, including monitoring, audits and day-to-day contact- Conducting internal training in sterilisation and in release of sterile products

Supporting R&D projects with knowledge within the biological field. Development of enzyme activity assay.

Denmark

Drove the Design Control and Risk Management processes in product development projects, from planning phase to reporting and final documentation. Deeply involved in the projects to ensure alignment and knowledge build up across the team as well as the progress of the project.Additional tasks:- Ensuring solid product design documentation before handover from development to full scale production- Managed change requests and specifications activities in development projects- Support the organisation with product knowledge- Maintain and improve relevant procedures- Coordination with the R&D test laboratory- Core group member of the company template working group- Core group member of the specification improvement project creating the URS for the new corporate specification system. This included facilitating global workshops with the purpose of defining the future specification management system

Managed change requests in all projects ensuring compliance with the regulatory standards and alignment between all ongoing changes.Ad hoc tasks in the QA department such as production deviations, complaints handling, support to productionand writing / reviewing instructions.

Study Director for cytotoxicity and hemocompatibility tests according to ISO 10993-5/USP (87) and ISO 10093-4. Study Supervisor for genotoxicity tests according to 10993-3. The test materials included medical devices, pharmaceuticals and industrial chemicals, and all work was done in accordance with GLP.

In charge of the Design History File (DHF) and Risk Management process in a big platform upgrade project that included medical device class III drug-device combination products.Part of the core group defining the requirements to a new enterprise content management system (Documentum), and part of transferring all paper based DHFs to the electronic system.

Did research for my master thesis "Effects of the Antifouling Compounds Tributyltin and Zinc Pyrithione on Marine Macroalgae"

M.Sc., Biology

Biology