Global leader in the medical device industry with a patient-focused culture of innovation
Product Quality Clinician
Location
Spain
Posted
2 days ago
Salary
0
Seniority
Senior
Job Description
Product Quality Clinician
Edwards Lifesciences
• 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.
Job Requirements
- 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)
Benefits
- Competitive Compensation and Benefits package
- Flexible working hours, remote working
- Pension plan
- Life Insurance
- Medical plan
- Meal Vouchers
- Service Awards
- Enhanced Leave benefits
- Employee Stock Purchase Programme
- Employee Assistance Programme
- Comprehensive Wellness programme including gym membership reimbursement, fresh fruit in the office, yoga lessons, subsidized massages, mindfulness sessions, educational events, charity activities and much more.
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