At Edwards Lifesciences, we’re committed to operating with honesty, openness, and fairness. Compliance with the highest levels of integrity is vital to building and maintaining the many trusted relationships that sustain our reputation and credibility. Your dedication to operational excellence will ensure employee business practices meet Edwards’ high ethical standards and continue to enable us to transform patient lives around the world.
The role:
Provide clinical expert knowledge and clinical guidance to Quality Specialists to understand the nature of complaints and possible health risks.
How You Will Make an Impact:
• 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.
• Educate complaint staff to understand the medical aspects of complaint information and associated procedures including health risks.
• 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.
• 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
• Other incidental duties
What you will need:
Bachelor's Degree or Equivalent in related field , 4-5 years years experience of previous related experience in a Medical Device Industry, Quality System, hospital/clinical environment (i.e. cardiac care, ICU, OR, or cardiovascular/endovascular interventions)
Previous experience working in a large manufacturing company (Preferred)
What else we look for:
• Strong presentation and public speaking 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
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive 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
• 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
What is it like to work at Edwards Lifesciences in Spain?
As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.
We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).
Edwards Lifesciences in Spain also offers the following benefits:
Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefits policy and components may vary by location.
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