Quality Engineer

Oferta confidencial; Tijuana; Presencial; MXN 180.000 - 240.000; Jornada completa

Descripción de la vacante

Oferta confidencial in Mexico is seeking a Quality Assurance professional to analyze customer data, audit materials and processes, and maintain GMP/ISO13485 standards across manufacturing.

The role includes supporting QMS documentation, local and global CAPA activities, KPI monitoring, audits, change control, and training to ensure product conformance and regulatory compliance with FDA/GM P guidelines.

Formación

• 3-5 years experience in QMS of Medical Device Manufacturer.
• Experience with FDA/ GMP guidelines.
• Ability to analyze data and monitor KPIs.
• Experience with CAPA processes.

Responsabilidades

• Analyze customer data, complaints and issues; audit materials and processes.
• Maintain GMP/ISO13485 standards across manufacturing.
• Surveillance of calibration equipment and processes; process validation support.

Conocimientos

Quality assurance

Data analysis

Regulatory compliance

GMP ISO 13485 familiarity

CAPA management

Documentation control

Herramientas

QMS software

PFMEA

Statistical analysis

Descripción del empleo

Quality Assurance

Analysis 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 Complaints

Contribute 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. QMS

Support QMS in local Document Control system according to global 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 Validation

Quality 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 needed

Profess. Knowl.: GDP, Statistical Analysis, Six Sigma or similar, ISO 13485, 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.