Omnex Consultant ISO

Overview Omnex, Inc., a global consulting, training and software development company ( based in Ann Arbor, MI, is looking for highly qualified consultants to support work in the Medical Device Sector. Qualifications Quality professionals with extensive hands‑on experience in: Quality Management Systems (ISO 13485, 21 CFR 820) Regulatory Standards Other parts of the US 21 CFR dealing with Medical Devices (i.e., parts 4, 11, 50, 99, 800, 801, 803, 806, 807, 808, 810, 812, 814, 820, and etc.) MDR (EU 2017/745, 746) MDSAP Risk Management (ISO 14971 & ISO 24971) SaMD (Software as a Medical Device), & SiMD (Software in a Medical Device) IEC ISO 62304 FDA Guidance IMDRF Guidance Cybersecurity Guidance Core Tools (APQP, FMEA, MSA, SPC, & PPAP) Auditor background and experience would be a plus. Also, a good working knowledge of other ISO Management systems & standards would be a plus. A self-starter with a minimum of 1–5 years’ experience in the Medical Device Industry and a Bachelor’s Degree is preferred. #J-18808-Ljbffr