Product Quality Clinician, Imaging

🔥 8 minutes ago

🌐 Spain, Ireland, +2 more countries – Remote

🇪🇸 Spain – Remote 🇮🇪 Ireland – Remote 🇵🇹 Portugal – Remote 🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Clinician

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Edwards Lifesciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1958

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Edwards Lifesciences is a global leader in patient-focused medical innovations. The company specializes in heart valve disease solutions, offering products and services such as transcatheter heart valves and mitral and tricuspid technologies, as well as surgical heart valve solutions. Edwards Lifesciences also focuses on critical care technologies including hemodynamic monitoring, remote monitoring, and predictive monitoring. The company conducts clinical research and is committed to improving patient lives through innovative cardiovascular disease solutions, while being a responsible corporate citizen with an emphasis on global corporate giving.

📋 Description

• Apply professional expertise and judgment to support product quality activities and business outcomes • Provide medical/clinical guidance and final direction to complaint staff and engineers on event interpretation, investigation, coding, regulatory reporting, and complaint closure • Author and/or review complaint conclusions, closure statements, and customer communications, including complex or novel cases • Evaluate information from clinical specialists, sales staff, physicians, nurses, hospital staff, and customers to support complaint investigations and resolve complex cases • Evaluate simple and complex cardiovascular imaging, including Echo, Fluoroscopy, and CT Scan • Provide clinical input to Product Risk Assessments and collaborate with Product Safety on Decision Rationale Matrices, reporting evaluations, and clinical or patient-risk decisions • Develop and deliver clinically based training to complaint staff and engineers • Review regulatory submissions, regulatory agency requests, and ad hoc clinical analyses • Communicate clinical conclusions, complaint data, trends, and patient-risk information to internal Quality, Manufacturing, Product Safety, and Product Development stakeholders • Participate as a clinical SME in cross-functional discussions and audits • Perform or provide clinical interpretation for complaint-related activities, including review of clinical records, procedural information, literature, images, videos, and other clinical data • Identify and support process improvement, clinical standardization, and development or revision of procedures, tools, and training materials • Provide consultancy to the quality compliance team • Consult in project settings within specific sections of quality compliance • Represent leadership on project sections while interfacing with managers and the quality compliance team • Perform other incidental duties

🎯 Requirements

• Bachelor's Degree or Equivalent in related field • 5 years of previous related experience in a Medical Device Industry, Quality System, hospital/clinical environment (i.e. cardiac care, ICU, OR, or cardiovascular/endovascular interventions) • Moderate knowledge and understanding of principles, theories, and concepts relevant to cardiovascular imaging • Digital capabilities (Power BI, Power Automate) and AI knowledge • Excellent facilitation, presentation, and public speaking skills • Proven successful project management skills • Proven expertise in Microsoft Office Suite, including advanced Excel, and QMS (Quality Management System) • Excellent documentation and communication skills and interpersonal relationship skills including relationship management skills with ability to drive achievement of objectives • Recognized as an expert in own area with specialized depth within the organization • Expert understanding of International Quality System Regulations • Working knowledge of Medical Device regulations and other applicable regulatory requirements • Adherence to company rules and requirements, including pandemic protocols and Environmental Health & Safety rules