Sr. Quality Clinical Imaging Specialist

Edwards Lifesciences • Irvine, CA

1d • $108,000 - $153,000

About The Position

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. In this role, you will assess and investigate complaint product device failures and patient adverse events for commercial and clinical products in collaboration with Complaint Handling, Quality/R&D/Clinical Development Engineers, Quality Compliance and Clinicians, and product safety. Collect, organize, and communicate information and data associated with complaint investigation activities, including escalation of crucial information to complaint team management

Requirements

• Bachelor's degree or equivalent in biological or life sciences, animal science or equivalent work experience based on Edward’s criteria, (or Associates degree and 8 years experience or high school diploma with 11 years experience), or in other related scientific or technical field,
• 5 years’ experience of previous in-hospital and/or industry clinical echocardiographic experience or equivalent work experience based on Edward’s criteria or in Certification in RDCS (Registered Diagnostic Cardiac Sonographer) within ARDMS (American Registry for Diagnostic Medical Sonography) or equivalent work experience based on Edward’s criteria or in equivalent certification, or
• 7 years’ experience of previous related experience or equivalent work experience based on Edwards criteria

Nice To Haves

• Excellent problem-solving, organizational, analytical, and critical thinking skills, including high discretion/judgment in decision making.
• Excellent written and verbal communication skills and interpersonal relationship skills
• Excellent computer skills in Microsoft Office Suite, including Word, Excel, and PowerPoint and related system(s)
• Good leadership skills
• Strict attention to detail
• Ability to manage competing priorities in a fast-paced environment.
• Ability to interact professionally with all organizational levels
• Requires strong diplomacy, influencing and relationship management skills
• Full knowledge of relevant imaging equipment operation (e.g., 2D or 3D TTE/TEE/ICE, CT, MRI, others)
• Good imaging analysis software skills (e.g., 3Mensio, TomTec, Vitrea, Circle VI, etc.).
• Substantial knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance
• Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• 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

Responsibilities

• Using imaging analysis software, perform analysis on various medical imaging modalities, accurately document findings in relevant reports, and quality management systems to support event investigation.
• Lead weekly case review calls with complaint investigators and summarizes and circulate appropriate documentation and findings.
• Collaborate with various stakeholders (e.g. Clinical, Professional Education, Field teams) to develop required materials for training and education as part of a prevention/mitigation plan.
• Plan, organize and prioritize complaint investigation activities based on complaint closure and reportability timelines.
• Identify and contribute to brainstorming to identify root causes and preventative actions within a cross-functional team
• Generate overview reports to provide data for weekly meetings
• Develop new metrics and tools to document all analysis activities and track complaints trends. In addition, research and develop techniques to accurately assess complex imaging findings.
• Provide coaching, mentoring, and knowledge transfer to team members
• Other incidental duties

Benefits

• Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees