Quality Engineer II - Alajuela
Must-have:QA/Test
Machine translation — original language: Spanish.Show original
Job Objective
Ensure compliance with quality standards, regulatory requirements, and applicable regulations through the execution, monitoring, and improvement of quality systems, validation processes, risk analysis, and quality investigations, contributing to the optimization of production processes, fulfillment of performance indicators, and the delivery of products that meet the highest quality levels.
Main Responsibilities
- Ensure compliance with the Quality System and FDA, GMP, and ISO 13485 standards.
- Lead and support quality investigations related to non-conforming materials (NCMR), corrective and preventive actions (CAPA), deviations, and product complaints.
- Participate in validation and qualification activities for products and processes (IQ, OQ, PQ, PPQ).
- Develop advanced statistical analyses for process monitoring and improvement using tools such as Minitab.
- Execute risk analysis and FMEA to ensure process quality and performance.
- Work closely with Manufacturing, Engineering, Research and Development, Quality, and Regulatory Affairs areas.
- Provide support during internal and external audits.
- Drive continuous improvement initiatives oriented towards process optimization, cost reduction, and indicator compliance.
Requirements
- University Bachelor's degree in Engineering or STEM careers (Science, Technology, Engineering, or Mathematics).
- Minimum 1 year of experience in Quality or Engineering positions.
- Knowledge in statistical analysis, data interpretation, and preparation of technical reports.
- Experience in environments regulated by FDA, GMP, and ISO 13485.
- Proficiency in Microsoft Office (Excel, Word, and PowerPoint).
- Intermediate English (B1-B2).
- Knowledge of quality and continuous improvement tools:
- FMEA
- Root Cause Analysis
- Fishbone
- Six Sigma
- SPC (Statistical Process Control)
- Non-conforming material control
- CAPA
This is an excellent opportunity for professionals who wish to strengthen their experience in quality within a leading advanced manufacturing company, participating in high-impact projects and working under international standards.
Apply now and take your career to the next level! .
-Requirements-
- Minimum education: Bachelor's / High School
- 2 years of experience
- Keywords: calidad, quality, qa, ingeniero, engineers, ingeniera, ing, engineer