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Edwards Lifesciences Engineer I in Haina, Dominican Republic

Description/ Role Purpose

As a quality engineer you are part of the continuous improvement of our product quality and quality management system.Ensure the company is always positioned as a key preferred supplier within the medical devices industry.Designs and installs quality control process sampling systems, procedure and statistical techniques. Designs specific testing mechanism, equipment and devices. Implement and sustain process improvement projects. Works with quality systems for re-engineering.

Job Functions

  • Develops and maintains methods and sampling procedures for inspections, testing and evaluation. Supports Quality Operations to ensure that products and processes comply with the relevant requirements of the Quality Management System.

  • Responsible for leading multifunctional teams to develop risk assessment activities, as part of Advanced Quality Planning system; creating and maintaining files including Process Map, FMEA and Plans focused on controlling the product quality. Supports process improvement plans and strategies that are designed to mitigate the risks identified through Risk Management process.

  • Support product/process transfer projects to assure compliance with procedures, as well as facilitation of activities required in the transfer.

  • Responsible for assuring validation / qualification of equipment, (including software) and process following appropriate procedures and meeting regulatory compliance requirements.

  • Develop and support continuous improvement activities to enhance the Quality Systems, using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, SPC, Kaizen lean methods, DOE, etc.

  • Collaborate and work in the development, implementation and sustaining of the project management program to guarantee projects proper implementation.

  • 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.

Education / Experience

  • Bachelor's degree in Engineering or related field (required)

  • No experience required

Required skills

  • Good computer skills in usage of MS Office, experience preferred.

  • Basic documentation, communication and interpersonal relationship skills.

  • Basic understanding of statistical techniques.

  • Good understanding and knowledge of principles, theories, and concepts relevant to Engineering.

  • Good problem-solving, organizational, analytical and critical thinking skills.

  • Good 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 immediate supervisor and other team members in the section or group.

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. 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 helping patients regain and improve the quality of their life.

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