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Engineering Quality Specialist

hace 2 semanas

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, improving patient outcomes and enhancing lives.

About the Role

We are seeking a highly skilled Engineering Quality Specialist to join our team. In this role, you will apply quality engineering principles and methods to ensure compliance with regulatory requirements and optimize product development, internal and external device manufacturing, and device distribution.

Key Responsibilities:
  • Investigate moderately complex 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.
  • Optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.
  • Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes and reduce risk.
Required Skills and Qualifications:
  • Bachelor's Degree in Engineering or Scientific field, 2 years min. of experience required or Master's Degree or equivalent in with internship, senior projects, or thesis in Engineering or Scientific field including either industry or education required.
  • Good computer skills in usage of MS Office Suite; CAD experience preferred.
  • Good documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills.
  • Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering.
  • Solid problem-solving, organizational, analytical, and critical thinking skills.
  • Solid understanding of processes and equipment used in assigned work.
  • Knowledge of and adherence to Quality systems.
  • Strict attention to detail.
  • Ability to interact professionally with all organizational levels.
  • Ability to manage competing priorities in a fast-paced environment.
  • Must be able to work in a team environment, including the ability to manage vendors and project stakeholders.
  • Ability to build productive internal/external working relationships.
  • Adhere to all company rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.