Assoc Spec, 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:

• Assist with senior team members with complaint investigations

• Investigate routine complaints

• Evaluate event to determine if it qualifies as a complaint

• Manage customer relationship and expectations during course of complaint investigation and resolution process

• Assist with assessment of complaint information provided and conduct additional investigation as directed and escalate as appropriate

• May evaluate complaints for Medical Device Reporting (MDR)

• May prepare and submit MDR reports to FDA

• Summarize routine 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

• May prepare and submit final customer correspondence

• Other duties assigned by Leadership (Identify basic problems with processes, procedures, and/or practices, and recommend solutions, including devising new approaches to problems encountered)

What you'll need (Required):

• Bachelor's Degree in in related field, 1 Year experience previous complaint handling experience or equivalent work experience based on Edwards criteria

What else we look for (Preferred):

• Good computer skills in MS Office Suite and ability to operate general office machinery

• Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment or equivalent work experience based on Edwards criteria

• Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred

• Good written and verbal communication skills and interpersonal relationship skills

• Good problem-solving and critical thinking skills

• Moderate knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance

• Basic knowledge of medical terms and human anatomy

• Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations

• Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing

• Ability to manage confidential information with discretion

• Attention to detail

• Ability to interact professionally with all organizational levels

• Ability to manage competing priorities in a fast paced environment with guidance

• Must be able to work in a team environment, including immediate supervisor and other team members in the section or group

• Ability to build stable working internal/external relationships

• 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

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.