Night Clinical Quality Specialist – Medical Devices Remote

Colvetsevilla; Valencia; Remote; EUR 90,000 - 130,000; Full time

Job summary

Edwards Lifesciences is seeking a full‑time clinical quality specialist to support product quality activities across a global remote environment. You will provide clinical guidance for complaint investigations, regulatory reporting, and risk assessments, working with engineers and medical staff to ensure patient safety.

Ideal candidates have a Bachelor’s in a related field and 5 years in medical device quality.

Qualifications

• Bachelor's Degree or Equivalent in related field, 5 years' of experience in a Medical Device Industry, Quality System, hospital/clinical environment.
• Moderate knowledge and understanding of principles, theories, and concepts relevant to cardiovascular imaging.

Responsibilities

• Provides clinical expert knowledge and clinical guidance to support product quality activities and business outcomes.
• 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 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 analyses.
• Communicate clinical conclusions, complaint data, trends, and patient-risk information to internal stakeholders in Quality, Manufacturing, Product Safety, and Product Development.
• Perform and/or provide clinical interpretation for additional complaint-related clinical activities as needed.
• Identify and support process improvement opportunities, clinical standardization activities, and development or revision of relevant procedures, tools, and training materials.
• Other incidental duties

Skills

Clinical knowledge

Regulatory knowledge

Quality systems

Medical device

Education

Bachelor's degree in related field

Tools

Power BI

Power Automate

Microsoft Excel

QMS

Job description

Edwards Lifesciences is seeking a full‑time clinical quality specialist to support product quality activities across a global remote environment. You will provide clinical guidance for complaint investigations, regulatory reporting, and risk assessments, working with engineers and medical staff to ensure patient safety.

Ideal candidates have a Bachelor’s in a related field and 5 years in medical device quality.