Product Quality Clinician, Imaging

Edwards Lifesciences

. Apply professional expertise and judgment to support product quality activities and business outcomes .

Posted 9/29/2026full-timeRemote • Spain, Ireland, Portugal, United KingdomMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in cardiovascular imaging and medical device regulations, providing clinical guidance and support for complaint investigations. Skilled in project management, quality compliance, and effective communication with cross-functional teams.

Highest-signal resume keywords

Cardiovascular Imaging ExpertiseQuality Management System (QMS)Regulatory Compliance KnowledgeProject Management SkillsClinical Training Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical InterpretationComplaint InvestigationRegulatory ReportingData AnalysisDocumentation SkillsProcess ImprovementClinical Risk AssessmentComplaint ClosureMedical Device RegulationsCardiac Care Knowledge

Soft Skills

Interpersonal Relationship SkillsFacilitation SkillsPresentation SkillsPublic Speaking SkillsCommunication Skills

Tools & Technologies

Microsoft Office SuitePower BIPower AutomateQuality Management System (QMS)

Industry Keywords

Medical Device IndustryQuality SystemCardiovascular InterventionsEnvironmental Health & SafetyClinical SME

About the role

Key responsibilities & impact

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

What you’ll need

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