TECH PROFESSIONALS

TECH PROFESSIONALS - Novozen Healthcare LLC, - South Plainfield, NJ South Plainfield, NJ & various unanticipated locations throughout the U.S.: QUALITY ENGINEERS: Anlyz prdct specs & dsgn chngs. Dvlp apprchs & mthds based on new Medical Device Regulation rqmts. Prep dsgn prcss flow, ctrl plan, inspctn plan & vldtn docs. Implmnt CAPA actions to prvnt noncnfrmnce relating to prdct, procss, & oprtng stndrds. Test prtype devices & prep rprts. Job 192: Skills req'd: Java, C++, MATLAB, CAD, ISO 14971, ISO 3485, Minitab and HTML. Job 129: Skills req'd: CAPA, Six Sigma, FMEA, DFMEA & PFMEA, IQ, OQ, PQ and Kaizen. BOTH: Master's in Sci, Tech, or Engg(any) w/6mos exp in job offrd or rltd occup is req'd. REGULATORY AFFAIRS SPECIALISTS: Gthr & anlyz info for prdct codes, device desc, FDA listing nos & GMDN codes. Dsgn, dvlp, test, docmnt & support of cGxP sys as per 21CFR Part11 & US FDA. Create master & risk mgmt plans, chnge requests, traceability matrix, & summary rprts. Prep, review, authrze & submit docs for quality complnce & regulatory authorities. Skills req'd: EU MDR, ISO 13485, cGMP, IQ/OQ/PQ, MDSAP, 93/42 EEC & eCTD. Master's in Sci, Tech, or Engg(any); Chem, Pharm, Bio, Health Sci, Reg Affairs or any rltd field w/ 6mos exp in job offrd or rltd occup is req'd. BOTH JOBS: Mail Resume: HR, Novozen Healthcare LLC, 2110 Maple Ave, Ste B1, South Plainfield, NJ 07080recblid g9k4sqowtzdid6hjt0fbkd4m8r83i0