Senior 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. 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 and conduct additional investigation as needed and escalate as appropriate Seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations Evaluate complaints for Medical Device Reporting (MDR) Prepare and submit MDR reports to FDA Identify problems and lead projects to improve processes, procedures, and/or practices; recommend and resolve solutions, including devising new approaches to problems encountered 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 Evaluate event to determine if it qualifies as a complaint Manage customer relationship and expectations during course of complaint investigation and resolution process Prepare and submit final customer correspondence Lead and plan agenda for and run 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 Analyze and/or audit complaint data/files and may develop reports Lead the investigation of complaints that include all complex scenarios: Other duties assigned by Leadership (Attend cross-functional meetings to represent Quality Compliance and present open items for which resolution is needed)What you'll need (Required): Bachelor's Degree in related field, 5 years experience complaint handling Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environmentWhat 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 including consultative and relationship management skills Demonstrated problem-solving , critical thinking, and investigative skills working relationships Substantial knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance Proficient 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 key contact representing the department on 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/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 $80,000 to $113,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.