Ingeniero de Calidad

About the role

We are looking for a Quality Engineer to ensure compliance with the established Quality System and GMP/ISO standards within our manufacturing environment. The role supports risk management, process validation, and continuous improvement activities.

Key responsibilities

• Verify company compliance with the Quality System, GMP and ISO standards.
• Support risk management activities, including FMEA.
• Conduct technical and statistical investigations to optimize processes and meet specifications.
• Measure process capability, control processes and assist with validation efforts.
• Collaborate with microbiology to ensure proper environmental monitoring and microbiological requirements.
• Investigate NCMR, out‑of‑tolerance calibrations and manufacturing complaints.
• Complete and document monthly quality data reviews.
• Lead Build‑At‑Risk authorizations and closures.
• Review and approve document change requests ensuring accuracy and compliance.
• Create and maintain quality plans and reports, often under senior engineering mentorship.
• Execute IQ, OQ, PQ, PPQ and method qualification activities.
• Perform advanced statistical analysis using Minitab.
• Maintain master validation plans and reports.
• Support major quality system investigations (CAPA, HHE, Stop‑Ship, etc.).
• Assist in preparation and execution of internal and external audits.

Required profile

• Bachelor’s degree in Engineering or a related field.
• Minimum 1 year of experience in quality engineering.
• Familiarity with regulated environments (FDA, GMP, ISO 13485).

Required skills

• MS Excel, Word, PowerPoint
• Minitab for statistical analysis
• FMEA and risk analysis techniques
• Root Cause Analysis, Fishbone diagrams
• Six Sigma and Statistical Process Control (SPC)
• Process validation (IQ, OQ, PQ, PPQ)
• Knowledge of FDA regulations, GMP and ISO 13485 standards