Quality Engineer IV – Shift Admin (Alajuela, Costa Rica)

About the role

Abbott’s Electrophysiology (EP) division in Alajuela, Costa Rica is seeking a Quality Engineer IV to support manufacturing and engineering activities. The role focuses on sustaining compliance with quality system requirements, driving key performance indicators, and supporting product validation and regulatory activities.

Key responsibilities

• Verify adherence to the Quality System, GMP, and ISO standards across manufacturing processes.
• Lead risk management activities, including FMEA and other analyses, and support design verification and validation.
• Conduct NCMR, calibration out‑of‑tolerance, and complaint investigations, and document findings.
• Own process capability measurement, process control, and validation efforts, collaborating with microbiology for environmental monitoring.
• Lead Build‑At‑Risk authorizations, document change requests, and maintain quality plans and reports.
• Execute IQ, OQ, PQ, and PPQ qualifications, and perform advanced statistical analyses using Minitab.

Required profile

• Bachelor’s degree in a STEM field (engineering preferred) with 4‑6 years of relevant experience.
• Proficiency with Microsoft Office applications (Excel, Word, PowerPoint).
• Strong knowledge of statistical data analysis and process‑improvement tools such as Root Cause Analysis, Six Sigma, and SPC.
• Experience with FDA, GMP, and ISO 13485 regulated environments.

Required skills

• MS Excel
• MS Word
• MS PowerPoint
• Statistical data analysis
• Minitab
• Root Cause Analysis
• Six Sigma
• Statistical Process Control (SPC)
• FDA/GMP/ISO 13485 compliance

What we offer

• Career development opportunities within a global healthcare leader.
• Recognition as a top workplace with strong commitment to diversity and inclusion.