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. You will also fulfill FDA, ISO and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies.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 Assist in planning agendas and running weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint Other duties assigned by Leadership (May assist in auditing complaint files)What you'll need (Required):Bachelor's Degree in related field , 3 years’ experience complaint handling.Medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment.What else we look for (Preferred): Proven expertise in MS Office Suite and ability to operate general office machinery 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/controlAligning 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.The base pay range for this position is $65,000 to $92,000(highly experienced). The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
