Product Quality Clinician, Imaging

This is a fully remote position, open to applicants in Spain, +3 more countries.

📋 Description

• Utilize professional expertise and judgment to enhance product quality initiatives and achieve business goals.

• Offer medical and clinical guidance as well as final direction to complaint personnel and engineers regarding event interpretation, investigation, coding, regulatory reporting, and complaint resolution.

• Draft and/or review conclusions related to complaints, closure statements, and customer communications, especially for complex or unique cases.

• Assess information from clinical specialists, sales personnel, physicians, nurses, hospital staff, and customers to aid in complaint investigations and address intricate cases.

• Analyze both simple and complex cardiovascular imaging modalities, including Echocardiography, Fluoroscopy, and CT Scanning.

• Contribute clinical insights to Product Risk Assessments and collaborate with Product Safety on Decision Rationale Matrices, reporting evaluations, and clinical or patient-risk determinations.

• Design and deliver clinically-oriented training sessions for complaint personnel and engineers.

• Review regulatory submissions, respond to regulatory agency inquiries, and conduct ad hoc clinical analyses.

• Convey clinical findings, complaint data, trends, and patient-risk information to internal stakeholders in Quality, Manufacturing, Product Safety, and Product Development.

• Act as a clinical Subject Matter Expert (SME) during cross-functional discussions and audits.

• Execute or provide clinical interpretations for complaint-related tasks, including reviewing clinical records, procedural information, literature, images, videos, and other clinical data.

• Identify and advocate for process enhancements, clinical standardization, and the development or revision of procedures, tools, and training materials.

• Offer consultancy services to the quality compliance team.

• Provide consultation in project settings concerning specific aspects of quality compliance.

• Represent leadership on project segments while collaborating with managers and the quality compliance team.

• Carry out other incidental duties as required.

⛳️ Requirements

• Bachelor's Degree or Equivalent in a related field.

• 5 years of relevant experience in the Medical Device Industry, Quality Systems, or a hospital/clinical setting (e.g., cardiac care, ICU, OR, or cardiovascular/endovascular interventions).

• Moderate understanding of principles, theories, and concepts related to cardiovascular imaging.

• Proficiency in digital tools (Power BI, Power Automate) and knowledge of AI technologies.

• Exceptional facilitation, presentation, and public speaking abilities.

• Demonstrated successful project management experience.

• Advanced proficiency in Microsoft Office Suite, particularly Excel, as well as Quality Management Systems (QMS).

• Strong documentation and communication skills, along with interpersonal skills that foster effective relationship management and the ability to achieve objectives.

• Recognized as an expert in their field, with specialized depth within the organization.

• Expert knowledge of International Quality System Regulations.

• Familiarity with Medical Device regulations and other relevant regulatory requirements.

• Commitment to adhering to company policies and regulations, including pandemic protocols and Environmental Health & Safety guidelines.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Competitive salary and performance-based incentives.

• Flexible work arrangements and a supportive work environment.