Product Quality Clinician
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives.With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Product Quality Clinician position is a unique career opportunity that could be your next step towards an exciting future.
How you will make an Impact:
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Provide clinical expert knowledge and clinical guidance to Quality Specialists to understand the nature of complaints and possible health risks.
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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.
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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.
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Provide clinical input to Product Risk Assessments (PRA), utilizing complaint data, clinical trends and predictive risk indicators where appropriate.
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Support the development and use of AI-enabled tools to enhance complaint evaluation, signal detection and quality decision-making.
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Review and interpret relevant imaging information in support of complaint investigations, product quality assessments and risk evaluations.
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Develop data visualization tools and dashboards to support quality monitoring, trend detection and management decision-making.
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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.
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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.
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May provide training to complaint staff on patient anatomy and medical conditions, products and procedures, and internal policies and procedures.
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Provide support in complaint data and relevant clinical information for regulatory submissions or regulatory agency requests.
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Mentor, coach, and provide training for other Clinicians Quality Compliance and Quality Specialists.
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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.
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Support Product Safety to maintain Decision Rationale Matrix to guide complaint staff and provide final direction on reporting decisions.
What you will need (Required):
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Bachelor's Degree or Equivalent in related field
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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)
What else we look for (Preferred):
- Use of AI-enabled tools
- Data visualization & analysis
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Excellent facilitation, presentation, and public speaking skills
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Proven successful project management skills
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Previous experience working in a large manufacturing company
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Proven expertise in both Microsoft Office Suite, including advanced Excel and QMS (Quality Management System)
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Excellent documentation and communication skills and interpersonal relationship skills including relationship management skills with ability to drive achievement of objectives
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Recognized as an expert in own area with specialized depth within the organization
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Expert understanding of International Quality System Regulations