Edwards Lifesciences Veterans Jobs

Job Information

Edwards Lifesciences Assoc Analyst, Quality Systems in Valencia, Spain

Improve and implement quality systems processes, including applications, documentation and training.

Key Responsibilities:

• Provide first-level help desk support to users, e.g., CAPA, including troubleshooting system issues, (e.g., system access, systems response) before escalating to IT if needed

• Participate on cross-functional teams for quality system projects

• Recommend changes to documentation associated with Quality Systems

• Generate quality system reports and review for accuracy

• Participate in the implementation of business process improvement solutions for Quality systems

• Participate on audit teams by responding and gathering data to address audit requests

• Assess the impact of quality systems information (e.g., Enterprise Change Requests (ECRs), CAPA) and provide feedback to originators

• Other incidental duties

Education and Experience:

• Bachelor's Degree or equivalent in in related field , 2 - 4 years experience Required

• Experience in a quality and/or manufacturing environment in the medical device industry preferred

• ISO13485 Internal Auditor or Lead auditor certification preferred

Additional Skills:

• Strong understanding of medical devices regulations (e.g. ISO13485)

• Good computer skills in MS Office Suite

• Good written and verbal communication skills and interpersonal relationship skills

• Good problem-solving and critical thinking skills

• Good knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality systems

• Good knowledge of medical or pharmaceutical regulations as relating to documentation

• 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

• Adhere to all EHS 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

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 13,000 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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