Specialist, Quality Compliance

Imagine how your ideas and expertise can change a patients 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. Youll bring your passion for problem solving and partner with various teams to influence decision-making for a products 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 patients unmet clinical needs. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring 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 youll 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

Demonstrated problem-solving critical thinking and investigative skills Ability to build stable working internal/external relationships

Full knowledge and understanding of Edwards policies procedures and guidelines relevant to quality compliance

Good 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

Must be able to work in a team environment including inter-departmental teams and representing the department on specific projects

Ability to build productive internal/external working 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.