Manufacturing Quality Assurance Engineer

hace 1 semana


Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completo
Company Overview
Edwards Lifesciences is a global leader in patient-focused medical innovations for structural heart disease, critical care, and surgical monitoring.
We collaborate with leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.

Job Description
As a Manufacturing Quality Assurance Engineer, you will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

About the Role
You will investigate basic manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations, and develop reports.
Additionally, you will optimize Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.

Your Responsibilities
- Investigate quality issues and provide recommendations
- Optimize manufacturing processes
- Identify opportunities for re-design/design of equipment, tools, fixtures, etc.
- Develop training and documentation materials
- Assign support tasks and instruct technicians

Requirements
Bachelor's Degree or Equivalent in Engineering or scientific field; work experience related required; Master's Degree or equivalent preferred.

Skills and Qualifications
- Good computer skills in usage of MS Office Suite; CAD experience preferred
- Basic documentation, communication, and interpersonal relationship skills
- Basic understanding of statistical techniques
- Previous experience working with lab/industrial equipment preferred
- Good problem-solving, organizational, analytical, and critical thinking skills
- Knowledge of and adherence to Quality systems

About Us
We are committed to helping patients regain and improve the quality of their life. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on innovation and excellence.

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