Remote Clinical Quality Specialist, Medical Devices

Edwards Lifesciences Belgium; Valencia; A distancia; EUR 90.000 - 110.000; Jornada completa

Descripción de la vacante

Edwards Lifesciences is seeking a qualified Quality/Clinical Specialist to support product quality activities and guide complaint investigations in a global setting. You will provide clinical interpretation, review imaging related to cardiovascular devices, and collaborate with engineers, regulatory, and manufacturing to drive compliant conclusions.

The role requires a Bachelor's degree and 5 years in medical device quality or clinical environment, with knowledge of regulatory requirements and

Formación

• Bachelor's Degree or equivalent in related field, 5 years’ 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 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 Regulations; Working 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

Responsabilidades

• 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.

Conocimientos

AI knowledge

Public speaking

Project management

Communication skills

Regulatory knowledge

Quality consulting

Process improvement

Educación

Bachelor's degree or equivalent in related field

5 years’ related experience in medical device industry/quality system

Herramientas

Power BI

Power Automate

Excel

QMS

Descripción del empleo

Edwards Lifesciences is seeking a qualified Quality/Clinical Specialist to support product quality activities and guide complaint investigations in a global setting. You will provide clinical interpretation, review imaging related to cardiovascular devices, and collaborate with engineers, regulatory, and manufacturing to drive compliant conclusions.

The role requires a Bachelor's degree and 5 years in medical device quality or clinical environment, with knowledge of regulatory requirements and