Quality Compliance Specialist, MDR Reporting

About the position Enjoy the flexibility of working remotely - this position is 100% remote within the U.S. 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. The Quality Compliance Specialist will 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. 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)

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)

Requirements

• Bachelor's degree plus five (3) years of experience with complaint handling and evaluating complaints for MDR (Medical Device Reporting); or equivalent work experience based on Edwards criteria.
• Medical Device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment/industry experience. Nice-to-haves
• Experience submitting Medical Device Reports
• Proficient knowledge of medical terms and human anatomy
• Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
• Strong knowledge and familiarity with 21 CFR 820 & 803 regulations
• Proven expertise in MS Office Suite and ability to operate general office machinery
• Excellent written

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