What are the responsibilities and job description for the Quality Management Consultant for Medical Devices position at Omnex Systems?
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:
Ø Quality Management Systems (ISO 13485, 21 CFR 820)
Ø Regulatory Standards
o Other parts of 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.)
o MDR (EU 2017/745, 746)
o MDSAP
Ø Risk Management (ISO 14971 & ISO 24971)
Ø SaMD (Software as a Medical Device), & SiMD (Software in a Medical Device)
o IEC ISO 62304
o FDA Guidance
o IMDRF Guidance
o Cybersecurity Guidance
Ø 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.