Innovation starts from the heart. Edwards Lifesciences is the leading integral 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.

La experiencia que se espera de los solicitantes, así como las habilidades y cualificaciones adicionales necesarias para este trabajo, se enumeran a continuación.
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.

- 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.

What you will need (Required):

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- 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).

What else we look for (Preferred):

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- Use of AI‑enabled tools.

- Data visualization & analysis.

- Excellent facilitation, presentation, and public speaking skills.

- Proven successful project management skills.

- Previous experience working in a large manufacturing company.

- 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

📌 Product Quality Clinician (Valencia)
🏢 Edwards Lifesciences
📍 Valencia