Specialist, Quality Compliance

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 apply professional expertise and judgment to support quality compliance activities and business outcomes.

How you will make an impact:

• Assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate
• Manage customer relationships and expectations during the course of complaint investigation and resolution process
• Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations
• Identify problems and lead projects to improve processes, procedures, and/or practices; recommend solutions, including devising new approaches to problems encountered
• Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA
• Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions
• Prepare and submit final customer correspondence
• Other duties assigned by Leadership (May assist in auditing complaint files)

What you'll need (Required):

• 3 years’ experience complaint handling or equivalent work experience based on Edwards criteria

What else we look for (Preferred):

• Proven expertise in MS Office Suite and ability to operate general office machinery
• Medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment or equivalent work experience based on Edwards criteria preferred.
• Excellent written and verbal communication skills and interpersonal relationship skills
• Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required