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

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

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)

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 "An.

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 of the.