Global Clinical Quality Assurance and Risk Management Specialist
Hermes Medical Solution is world leader in visualization and analysis of medical images in the field of molecular imaging. Founded in 1976 the company was the first to offer a workflow for digital images captured from available scanners.
Ever since the start Hermes Medical Solutions has continued to be a pioneer and has today an unparalleled diagnostic capability through a complete software solution supporting physicians in molecular imaging/nuclear medicine. Today Hermes Medical Solutions is established in 6 countries but has a global customer base comprising of more than 300 hospitals.
Backed by well-reputed Nordic private equity firm Segulah, Hermes Medical Solution is actively pursuing a growth agenda, which is also fuelled by a unique opportunity to help drive improvements in the quality of care for patient with all-too-common diagnoses such as Cancer, Dementia, and heart diseases.
Read more about the company and the products: https://www.hermesmedical.com/
Reports to: Vice President Quality & Regulatory
Location: Workplace at Hermes Medical Solutions Office in Stockholm, Sweden
Be a part of the team that performs troubleshooting customer use of Hermes software, testing and risk management in the Hermes organization.
Participate in various cross-functional development teams and be responsible for risk management, clinical evaluation as well as internal tests in different development projects.
The role also includes assistance in the risk management of reported complaints related to safety or clinical effectiveness.
Duties / Expectations of Role:
- Assess bugs reported by customers and Hermes staff and record details for development team when verified
- Assess risk events reported by customers
- Assist applications specialists with third line support
Internal Product Development
- Assist in identification of user, performance, and safety requirements in development projects
- Create verification and validation tests, risk assessment and risk mitigation for projects using software testing platform (JAMA)
- Usability assessment
- Test tickets for on-going software projects
- Work with developers to ensure accurate implementation of bug fixes and new features
- Oversee updating user and installation documentation for each software project
- Work with product specialists and product owner in planning new software versions
- Develop and maintain Clinical Evaluation Plans and Reports for Hermes applications
- Review and give input to Post-Marketing Surveillance
- Verify the relevant information compiled from clinical evaluation reports, clinical validations, peer review publications, risk management files and post market data
- Create Release documents describing new features and bug fixes for software projects
Communication with External bodies
- Assist in communication with Lead Auditors (FDA and similar authorities) on issues related to risk assessment and clinical validations
- Manage and/or perform additional tasks and projects, as assigned
- Exercise judgment independently
- Academic background in medical imaging as a hospital physicist or equivalent work experience
- Excellent written and verbal communications skills in English
- Strong ability to organize, interpret and disseminate product information
- Proficiency in MS Office applications
Nice to Have Requirements:
- Basic understanding of regulatory compliance for medical devices (or pharmaceuticals)
- Knowledge or experience of the standards ISO-14971, MEDDEV 2.7.1 Clinical Evaluation, IEC-62366 Usability
- Five to ten years of relevant experience
- Demonstrated project management skills
- Knowledge or experience of developing a software testing environment
- Confident (in a quality perspective way)
- Stress tolerant
- Ability to prioritize
- Communication abilities especially written
If you have any question or would like to know more about this new global position, please contact:
Senior Consultant Life Science, Agneta Almquist, PhD, Hudson Nordic.
Phone: +46 708-28 28 89, E-mail: email@example.com
We are going through applications continuously. We therefore urge you to apply for this position as soon as possible.