Quality Engineer (10 Openings)

Job Duties:

Applicants must have 6 mos of exp performing 3 - 4 of the following job duties: Support & implmt qlty systms & compliance stds across regulated mfg environments, focusing on FDA remediation & documentation compliance activities. Review, assess & update Device Master Records (DMRs), mfg instructions, validation protocols, reports & std operating procedures to ensure alignment w/ internal procedures & regulatory reqmts. Execute validation & qualification activities, incl

IQ, OQ & PQ.

Support test method validation & participate in risk mgmt updates such as

PFMEA & DFMEA.

Collaborate w/ cross-functional teams, incl Mfg, Engg, Oper'ns & Qlty to support investigations, root cause analysis, CAPA & continuous imprvmnt initiatives. Monitor documentation & qlty performance metrics by reviewing techn'l records & remediation deliverables, while supporting audit, inspection readiness & ongoing compliance imprvmnts w/in the Qlty Mgmt Systm (QMS) framework. Applicants must have 6 mos of exp in using 4 - 5 of the following techn'l terms: GMP, cGMP, GDP, GxP, ISO 13485, ISO 9001, IATF 16949, Qlty Mgmt Systms (QMS), CAPA, NCR/NCMR, Change Control, Deviation Mgmt, Risk Mgmt, DFMEA, PFMEA, AFMEA, Process Validation, Dsgn Controls, Dsgn History File (DHF), Device Master Record (DMR), Techn'l Documentation, IQ, OQ, PQ, PPQ, MSA, SPC, SQC, SOP dvlpmt, MDR reqmts, TrackWise, Veeva Vault, LIMS, SAP, ValGenesis, Kneat, MasterControl, root cause analysis.

Education/Exp Reqmts:

Master's deg or Foreign Equiv & 6 mos exp as Quality Engineer or Jr. Quality Engineer or in any rltd occupation performing 3 - 4 of the job duties & using 4 - 5 techn'l terms aforementioned.

Field of Study:

Engg & Oper'ns Mgmt or Biomedical Engg or Industrial Engg or Mechanical Engg or Chemical Engg or Qlty Engg or Life Sciences or Pharmaceutical Sci or Mfg Engg or any rltd field.

Job Locs:

Tampa, FL or any unanticipated client sites w/in the U.S. Must be available to travel nationally & relocate to any unanticipated client sites for temporary projects. Frequency of travel 50%, No int'l travel.

Benefits:

PTO, Medical, Dental & Vision Insurance.

Mail Resumes to:

ND Global Consulting Services, Inc., 15310 Amberly Dr, Ste 250, Tampa, FL 33647