Location
- Onsite 3 days a week in MA or MD
Duration
- 6 months, possibility to go perm; Onsite 3 days a week
Job Description
- Medical device client needs an SaMD Quality Manager. Must have class 2 and 3 device experience, contributed to the artifacts as a developer, programmer, or EE then moved into quality to handle patient safety. Must know ISO 14971, 62304, hazard analysis, fault tree analysis, FMEA / UFMEA, software FMEA, writing risk plans and summary reports, crafting and understanding standards and updating the SOPs. Drive team on ISO 14971 and SaMD best practices. Nice to have: Experience handling regulatory audits, how to position best for the review by FDA, BSI, TUV SUD. Device experience preferred include ventilators or defibs. Must have strong software experience. Looking for 10+ years of device experience.
Skills
- Software as a Medical Device (SaMD)
Education
- Computer Sci, EE, Biomedical preferred.
On-Site SaMD Quality Manager (235191)
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