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Omnex Consultant ISO 13485

Job

Omnex PlanTech Employment Opportunities

Ann Arbor, MI (In Person)

Full-Time

Posted 5 weeks ago (Updated 1 week ago) • Actively hiring

Expires 7/15/2026

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Job Description

Omnex, Inc., a global consulting, training and software development company (www.omnex.com) based in Ann Arbor, MI, has significant opportunities for highly qualified consultants to help with efforts in the
Medical Device Sector:
Quality Professionals with extensive hands-on experience in the following: 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. Self-starter with minimum 1-5 years experience in the Medical Device Industry would be preferred, along with a Bachelor s Degree. Interested individuals should send their resumes to resumes@omnex.com