Product Quality Clinician

🕒 July 13

🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Clinician

👻 Ghost score 25%

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

• Provide clinical expert knowledge and guidance to Quality Specialists for complaint assessment and health-risk evaluation • Analyze and interpret aggregate complaint, clinical, and post-market data, including trends, visualizations, and analytical summaries • Provide clinical input to Product Risk Assessments using complaint data, clinical trends, and predictive risk indicators • Support AI-enabled tools for complaint evaluation, signal detection, and quality decision-making • Review imaging information for complaint investigations, product quality assessments, and risk evaluations • Develop data visualization tools and dashboards for quality monitoring and management decisions • Develop clinically based training materials and educate complaint staff on medical aspects and health risks • Provide medical and clinical guidance on event interpretation, investigations, coding, regulatory reporting, and complaint closure • Review complaint conclusions, closure statements, and customer letters as needed • Train complaint staff on anatomy, medical conditions, products, procedures, and internal policies • Support regulatory submissions and regulatory agency requests with complaint and clinical information • Mentor, coach, and train Clinicians Quality Compliance and Quality Specialists • Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses, hospital staff, and customers to support investigations • Maintain the Decision Rationale Matrix with Product Safety to guide reporting decisions

🎯 Requirements

• Bachelor's Degree or Equivalent in related field • 5-7 years of previous related experience in a medical device industry, quality system, hospital/clinical environment, such as cardiac care, ICU, OR, or cardiovascular/endovascular interventions • Experience using AI-enabled tools preferred • Data visualization and analysis skills preferred • Excellent facilitation, presentation, and public speaking skills • Proven successful project management skills • Previous experience working in a large manufacturing company preferred • Expertise in Microsoft Office Suite, including advanced Excel, and QMS (Quality Management System) • Excellent documentation, communication, and interpersonal relationship skills • Ability to drive achievement of objectives • Expert understanding of International Quality System Regulations • Working knowledge of Medical Device regulations and other applicable regulatory requirements • Ability to provide consultancy to the quality compliance team • Ability to consult in project settings within quality compliance • Ability to represent leadership on project sections and interface with managers and the quality compliance team • Adherence to company rules, pandemic protocols, Environmental Health & Safety rules, injury prevention, environmental protection, and pollution prevention requirements

🏖️ Benefits

• Competitive Compensation and Benefits package • Flexible working hours • remote working • Pension plan • Life Insurance • Medical plan • Meal Vouchers • Service Awards • Enhanced Leave benefits • Employee Stock Purchase Programme • Employee Assistance Programme • Comprehensive Wellness programme including gym membership reimbursement, fresh fruit in the office, yoga lessons, subsidized massages, mindfulness sessions, educational events, charity activities and much more • On-the-job development • Training opportunities • Support and guidance provided by dedicated employee groups