Quality Engineer

Quality Engineer – Site TransferLocation: Las Américas Km. 22, Autopista Las Américas Santo Domingo, República Dominicana – Onsite all 5 daysType: Contract

Position SummaryWe are seeking a bilingual English/Spanish Quality Engineer to support manufacturing site transfer, qualification, and validation activities in the Dominican Republic. The ideal candidate will have strong hands-on experience with IQ/OQ/PQ, Process Validation, and Test Method Validation (TMV) and be able to independently lead validation activities from protocol development through execution, statistical analysis, and final reporting.
Key ResponsibilitiesSupport manufacturing and product site transfer activities.Independently develop and execute IQ, OQ, PQ, and Process Validation protocols.Lead Test Method Validation (TMV) activities, including Gage R&R and Attribute Agreement Analysis.Perform statistical analysis using Minitab, including Cp/Cpk and process capability analysis.Support qualification of equipment, tooling, inspection methods, and manufacturing processes.Participate in PFMEA, risk assessments, NCRs, CAPA, deviations, and change controls.Troubleshoot validation failures and conduct root-cause investigations.Collaborate closely with Manufacturing, Quality, Engineering, R&D, and Operations teams.Prepare validation documentation, protocols, and final reports.Ensure validation activities comply with applicable ISO 13485, ISO 14971, FDA, and GMP requirements.
Required QualificationsBachelor’s degree in Engineering or a related technical field.5+ years of Quality Engineering and/or Validation experience.Medical device manufacturing experience strongly preferred.Strong hands-on experience with:IQ/OQ/PQProcess ValidationTest Method Validation (TMV)Gage R&RAttribute Agreement AnalysisMinitabCp/Cpk and process capabilityExperience supporting manufacturing site transfers.Strong knowledge of PFMEA, CAPA, NCR, deviations, change control, statistical analysis, and risk management.Ability to work independently with minimal supervision.Must be willing to work onsite in the Dominican Republic.Bilingual English and Spanish is required.