Quality AssuranceAnalysis of customer data (Complaints/Issues).
Reviewing, auditing processes.Audit the correct methods of inspection of materials and processes through the use of approved procedures to ensure their quality in all stages of manufacturing.Surveillance of calibrated equipment and calibration process.Maintain the standards according to applicable regulation and the GMP, for the quality and conformation of the product.Analyze the necessary statistics to be able to monitor the non-conforming product.Costumer ComplaintsContribute with manufacturing during complaint investigations and investigation of reported issues.
maintaining the standards according to the FDA and the GMP, for the quality and conformation of the product.




QMSSupport QMS in local Document Control system according to general and regulatory requirements.Support QMS Sustaining of the global CAPA system according to regulatory requirement and support CAPA owners during all CAPA phases.To monitor local KPIs and perform data analysis and track action items out of the Management Review and QIT.To participate as during in process inspection audits.Support operations department with change control system.Provide the necessary training to all the personnel involved to support the needs of training system of the Quality Department.Process ValidationQuality Representative to review on IPL (Initial Production Lot) finding and result.Quality Representative to review Validation protocols and records.Quality representative to review PFMEA.
Maintain updated MVP and PFMEA.Distribution Quality Assurance Support Distribution QA/SQM when neededProfess.
Knowl.
: GDP, Statistical Analysis, Six Sigma or similar, ISO *****, Management of work teams,Methodologies: Presentation and Training Capabilities, GMP, Quality ControlSoft Skills: Communication and Team PlayerProficient EnglishDesired: Experience working with colleagues overseas in US, Europe and Asia.At least 3-5 years experience in QMS of Medical Device Manufacturer.
Experience in local and global project management.
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📌 Quality Engineer (Tijuana)
🏢 Empresa líder
📍 Tijuana