Product Quality Clinician

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Edwards Lifesciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1958

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance • Biotechnology • Medical Devices

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 clinical guidance to Quality Specialists to understand the nature of complaints and possible health risks. • Provide clinical expert knowledge, clinical data insights and risk evaluation guidance to Quality Specialists to support complaint assessment, trend identification, regulatory decision-making and potential health risk evaluation within Structural Heart therapies. • Analyze and interpret aggregate complaint, clinical and post-market data for a specific product line, business unit, regulatory submissions, regulatory agency requests and management reports, including trend identification, visualization and ad hoc analytical summaries. • Provide clinical input to Product Risk Assessments (PRA), utilizing complaint data, clinical trends and predictive risk indicators where appropriate. • Support the development and use of AI-enabled tools to enhance complaint evaluation, signal detection and quality decision-making. • Review and interpret relevant imaging information in support of complaint investigations, product quality assessments and risk evaluations. • Develop data visualization tools and dashboards to support quality monitoring, trend detection and management decision-making. • Support Product Safety in development of clinically based training materials and educate complaint staff to understand the medical aspects of complaint information and associated procedures including health risks. • Provide medical/clinical guidance and final direction to complaint staff related to event interpretation, event investigation, proper coding, required regulatory reporting, and complaint closure. • May review complaint conclusions/closure statements and/or customer letters. • May provide training to complaint staff on patient anatomy and medical conditions, products and procedures, and internal policies and procedures. • Provide support in complaint data and relevant clinical information for regulatory submissions or regulatory agency requests. • Mentor, coach, and provide training for other Clinicians Quality Compliance and Quality Specialists. • Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and drive towards resolution. • Support Product Safety to maintain Decision Rationale Matrix to guide complaint staff and provide final direction on 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 (i.e. cardiac care, ICU, OR, or cardiovascular/endovascular interventions)

🏖️ 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.