Responsibilities may include the following and other duties may be assigned.
- Ability to summarize data from variety of sources to draft post market surveillance reports on ongoing basis.
- Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.
- Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
- Represent client as appropriate in FDA, notified body, internal, and other audits.
- Other duties as assigned or required.
Nice to Have: Preferred Qualifications
- Experience in vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and/or guide wires.
- Extensive knowledge of quality tools:
Highly proficient in math and use of statistical techniques
Root cause analysis
Problem solving approaches
- FDA/ISO/MDD/EUMDR requirements and guidance
- Mastery of relevant software programs preferred - Microsoft Word, PowerPoint, Excel, and Project, and Minitab.
Sthree US is acting as an Employment Business in relation to this vacancy.
Total Quality Management
Provide Technical Guidance