Edwards Lifesciences Senior Quality Compliance Specialist (Complaint Handling) in Irvine, California
Position Overview :
Evaluate global complaint information provided, conduct additional investigation as needed and escalate as appropriate. Evaluate complaints for Medical Device Reporting (MDR). Prepare and submit MDR reports to FDA. Process complaint files from initiation to closure.
Fulfill FDA, ISO and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies.
Key Responsibilities :
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)
Required Qualifications :
Bachelor's Degree in related field plus 5 years of experience with complaint handling related responsibilities.
Experience within the Medical Device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment.
Preferred Qualifications :
Experience submitting Medical Device Reports
Strong knowledge and familiarity with 21 CFR 820 & 803 regulations
Proven expertise in MS Office Suite and ability to operate general office machinery
Experience working in a medical device industry
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
Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
Ability to manage confidential information with discretion
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 13,000 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.