Jessica Storm Email & Phone Number

Lund, Skåne County, Sweden

• Create clear, consistent, and user friendly technical documentation for complex IVD medical devices• Create text and illustrations for IFUs, service manuals, and other technical documentation• Ensure that the technical documentation complies with applicable regulations and standards• Responsible for the information for safety (ISO symbols, warnings, etc.)• Develop and maintain processes for producing, reviewing, and distributing technical documentation• Participate in risk management activities• Collaborate with SMEs

Lund, Skåne County, Sweden

• Coach and help team members grow in their role• Assist with strategic decision making regarding quality work• Internal Auditor (MDSAP, ISO 13485, EU IVDR, ISO14001)• Implement new and updated standards and regulations (including IVDD to IVDR)• Train employees in quality and QMS requirements• Nonconformity/ Complaint/ CAPA handling• Design Control/ Change control• Risk Management• Product Release

Lund, Sweden

Lund, Sweden

• QMS maintenance and development (ISO 13485, EU MDD, 21 CFR 820)• Training employees in quality and QMS requirements• Pre-market sumbissions and product registrations (EU class IIa and USA class II)• Audit coordinator• Management representative• Design control including risk management activities (ISO 14971) and technical documentation for Software as a Medical Device products (IEC 62304, IEC 82304-1)• Implement new and updated standards and regulations (including MDD to MDR)

Lund, Sweden

Lund, Sweden

Arrival tests, manufacturing, testing, troubleshooting, and repair of medical devices including documentation for quality assurance.Consultant through Academic Work.

Master'S Degree, Biomedical Engineering

Activities and Societies: E-sektionenFive-year program completed in 4.5 years Master in Signals, imaging and e-health Master thesis ".

Other, Information Technology

One academic year at Heriot-Watt University in Edinburgh where I recieved a special award for most outstanding student in year one.