Senior Manager, Clinical Product Quality – Medical Device, Complaint Handling, Cardiovascular RN

🔥 0 minutes ago

🌵 Arizona, California, +8 more states – Remote

🌵 Arizona – Remote 🏄 California – Remote ⛰️ Colorado – Remote 🐊 Florida – Remote 🌽 Illinois – Remote 🏖️ New Jersey – Remote 🌲 North Carolina – Remote ❄️ Minnesota – Remote 🤠 Texas – Remote ☕ Washington – Remote

💵 $145k - $205k / year

⏰ Full Time

🟠 Senior

👔 Manager

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Edwards Lifesciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1958

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Edwards Lifesciences is a global leader in patient-focused medical innovations. The company specializes in heart valve disease solutions, offering products and services such as transcatheter heart valves and mitral and tricuspid technologies, as well as surgical heart valve solutions. Edwards Lifesciences also focuses on critical care technologies including hemodynamic monitoring, remote monitoring, and predictive monitoring. The company conducts clinical research and is committed to improving patient lives through innovative cardiovascular disease solutions, while being a responsible corporate citizen with an emphasis on global corporate giving.

📋 Description

• Provide medical/clinical guidance to complaint investigators and engineers on event interpretation, investigation, coding, regulatory reporting, and complaint closure • Author and/or review complaint conclusions, closure statements, and customer letters • Assist with and help manage Imaging Reviews • Educate complaint investigators about events and potential health risks • Interpret complaint data for investigators, engineers, and Quality personnel • Author clinically based, product-specific scripts for complaint investigations • Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses, hospital staff, and customers to support investigations and resolution • Train complaint investigators on patient anatomy, medical conditions, IHFM products, and procedures • Provide complaint training to Sales, Marketing, and other customer-facing roles • Maintain the Decision Rationale Matrix with the VP Product Safety and/or Director of Quality • Review complaint codes and FDA Medical Device Reports and assist with reporting decisions • Analyze and interpret complaint data for product lines, business units, regulatory submissions, agency requests, and management reports • Perform Complaint Trending Analyses and participate in Quality Metrics Review and Quality Data Review meetings • Communicate complaint data and clinical information to Quality, Manufacturing, and New Product Development teams • Provide clinical guidance for FMEAs and Risk Management Worksheets • Provide clinical input to Product Risk Assessments and participate in Risk Management Councils and Quality Boards • Aid responses to regulatory agencies regarding complaint and Risk Management issues

🎯 Requirements

• Bachelor’s degree plus 10 years of relevant experience or equivalent work experience based on Edwards’ criteria • Registered Nurse (RN) - current state license active or expired • Cardiac patient care experience (e.g. cardiac care, ICU, OR, or cardiovascular interventions) • Medical device industry experience in Quality/Compliance, with a strong preference for complaint handling, complaint investigation, and/or post-market surveillance • RN with Cath Lab, CVOR, or CVICU nursing experience • Expert knowledge of the FDA’s Quality System Regulations and experience working within a Quality Management System • Strong working knowledge of Medical Device regulations, including FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR, CMDR, MDD 93/42/EEC, and other applicable regulatory requirements • Demonstrated subject matter expertise in clinical product quality, complaint handling, post-market surveillance, risk management, escalation, field action or related quality processes • Proven successful project management and cross-functional leadership skills • Ability to read and interpret Product Instructions for Use, Training and Procedure Manuals • Ability to write routine MDR (Medical Device Reports)/MIR (Manufacturer Incident Report) and routine correspondence • Ability to interpret patient medical records and clinical data to assess adverse events and potential device-related risks • Ability to speak effectively before groups of employees of organization • Ability to provide technical guidance, coaching, and feedback to peers and cross-functional partners without direct people-management responsibility • Experience in developing or delivering training programs • Knowledge of computer application programs including Excel, PowerPoint and Word • Excellent written and oral English communication skills

🏖️ Benefits

• Competitive salaries • Performance-based incentives • A wide variety of benefits programs to address the diverse individual needs of employees and their families