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Job Title:

Quality Engineer (10 Openings)

Job Duties:

Applicants must have six (6) months of experience performing 3-4 of the following job duties: Support and implement quality systems and compliance standards across regulated manufacturing environments, focusing on FDA remediation and documentation compliance activities. Review, assess and update Device Master Records (DMRs), manufacturing instructions, validation protocols, reports and standard operating procedures to ensure alignment with internal procedures and regulatory requirements. validation and qualification activities, including IQ, OQ and PQ. Support test method validation and participate in risk management updates such as PFMEA and DFMEA. Collaborate with cross-functional teams, including Manufacturing, Engineering, Operations and Quality to support investigations, root cause analysis, CAPA and continuous improvement initiatives. Monitor documentation and quality performance metrics by reviewing technical records and remediation deliverables, while supporting audit, inspection readiness and ongoing compliance improvements within the Quality Management System (QMS) framework. Applicants must have six (6) months of experience in using 4-5 of the following technical terms: GMP, cGMP, GDP, GxP, ISO 13485, ISO 9001, IATF 16949, Quality Management Systems (QMS), CAPA, NCR/NCMR, Change Control, Deviation Management, Risk Management, DFMEA, PFMEA, AFMEA, Process Validation, Design Controls, Design History File (DHF), Device Master Record (DMR), Technical Documentation, IQ, OQ, PQ, PPQ, MSA, SPC, SQC, SOP development, MDR requirements, TrackWise, Veeva Vault, LIMS, SAP, ValGenesis, Kneat, MasterControl, root cause analysis.

Education/Experience Requirements :

Masters degree or Foreign Equivalent and six (6) months experience as Quality Engineer or Jr. Quality Engineer or in any related occupation performing 3-4 of the job duties and using 4-5 technical terms aforementioned.

Field of Study :

Engineering & Operations Management or Biomedical Engineering or Industrial Engineering or Mechanical Engineering or Chemical Engineering or Quality Engineering or Life Sciences or Pharmaceutical Science or Manufacturing Engineering or any related field.

Job Locations :

Tampa, FL or any unanticipated client sites within the U.S. Must be available to travel nationally and relocate to any unanticipated client sites for temporary projects. Frequency of travel 50%, No international travel.

Benefits :

PTO, Medical, Dental and Vision Insurance.

Mail Resumes to:

ND Global Consulting Services, Inc. 15310 Amberly Drive, Suite 250, Tampa, FL 33647