Product Quality Clinician (Imaging)

Edwards Lifesciences Gruppe; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Edwards Lifesciences is seeking a Quality-focused clinical SME to support product quality activities throughout the lifecycle. You will apply medical expertise to investigations, provide clinical guidance to complaint staff and engineers, and influence decision-making to ensure patient safety and regulatory compliance.

You will review regulatory submissions, develop clinically based training, and collaborate with cross-functional teams on risk assessments and process improvements related to

Job description

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

How you will make an Impact:

Applies professional expertise and judgment to support product quality activities and business outcomes. Provide clinical expert knowledge and clinical guidance.

Provide medical/clinical guidance and final direction to complaint staff and engineers related to event interpretation, event investigation, proper coding, required 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, and other hospital staff/customers, as needed to independently support complaint investigation and drive complex cases towards resolution.

Evaluate simple and complex imaging such as Echo, Fluoroscopy, CT Scan...related to cardiovascular imaging

Provide clinical input to Product Risk Assessments and work with Product Safety to support Decision Rationale Matrices, reporting evaluations, and other clinical or patient-risk decisions.

Develop and deliver clinically based training to complaint staff and engineers on patient anatomy, medical conditions, products, procedures, clinical event interpretation, and applicable internal policies and procedures.

Review regulatory submissions, regulatory agency requests, or ad hoc clinical analyzes.

Communicate clinical conclusions, complaint data, trends, and patient-risk information to internal stakeholders in Quality, Manufacturing, Product Safety, and Product Development. Participate as clinical SME in cross-functional discussions and audits, as requested.

Perform and/or provide clinical interpretation for additional complaint-related clinical activities, which may include review of clinical records, procedural information, literature, images, videos, or other clinical data, based on expertise and business needs.

Identify and support process improvement opportunities, clinical standardization activities, and development or revision of relevant procedures, tools, and training materials.

Other incidental duties

What you will need (Required):

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

What else we look for (Preferred):

Digital capabilities (Power BI, Power Automate) and AI knowledge

Excellent facilitation, presentation, and public speaking skillsProven successful project management skills

Proven expertise in both 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 RegulationsWorking knowledge of Medical Device regulations, and other applicable regulatory requirements.

Provides consultancy to quality compliance team

Consult in project setting within specific sections of quality compliance area

Represents leadership on sections of projects within a specific area interfacing with managers and quality compliance team

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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

Sounds like your next step?

Meet the team

Edwards Lifesciences

Edwards Lifesciences is a medical device company focused on innovative therapies for patients with heart valve disease and other cardiovascular conditions. The company develops and commercializes transcatheter technologies, including the SAPIEN M3 Transcatheter Mitral Valve Replacement Therapy, designed to address unmet clinical needs for patients with mitral and tricuspid heart valve disease. Their Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit pursues innovative portfolios to help patients live longer and healthier lives through advanced minimally invasive treatment options.