Senior Manager, Clinical Product Quality - Medical Device/Complaint Handling & Cardiovascular RN

Edwards Lifesciences • Irvine, FL

3d • Remote

About The Position

This position offers the flexibility of being fully remote, but the selected candidate must be currently residing within the United States. Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. As a Senior Manager, Clinical Product Quality, you will be a member of Complaint Handling and Post Market Surveillance/Risk Management team to provide clinical guidance/clinical expert knowledge to Quality, Engineering and other cross functional teams to understand the nature of complaints and possible health risks. In this role you will ensure appropriate investigation of product complaints and adverse events, in order to escalate potential manufacturing, design, labeling and training issues. You will also follow standard practices and procedures in analyzing data, interpreting and drawing conclusions, with the objective of gathering key information and communicating to cross-functional teams who will utilize the information for improvement of product and procedural outcomes.

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

Nice To Haves

• RN with Cath Lab, CVOR, or CVICU nursing experience
• Expert knowledge of the FDA’s Quality System Regulations; experience working within a Quality Management System.
• Strong working knowledge of Medical Device regulations, such as 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 documents such as 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

Responsibilities

• Provides medical/clinical guidance to complaint investigators and engineers related to event interpretation, event investigation, proper coding, required regulatory reporting (Medical Device Reports, Medical Device Vigilance, etc.), and complaint closure.
• Author and/or review complaint conclusions/closure statements and customer letters.
• May assist with and help manage Imaging Reviews
• Educates complaint investigators to understand nature of events and possible health risks
• Interprets complaint data for complaint investigators, engineers, and other Quality department personnel
• Authors clinically based product specific scripts to guide complaint investigators in appropriate investigational paths
• Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and drive towards resolution
• Provides training to complaint investigators on patient anatomy and medical conditions, and IHFM (Implantable Heart Failure Management) products and procedure
• Provides complaint training to Sales, Marketing and other customer facing roles
• Works with VP Product Safety and/or Director of Quality to maintain Decision Rationale Matrix to guide complaint investigators with reporting decisions.
• Reviews complaint codes and FDA Medical Device Reports, reviews and assists with reporting decisions
• Authors and/or reviews complaint conclusions/closure statements and customer letters
• Analyzes and interprets complaint data for a specific product line, business unit, regulatory submissions, regulatory agency requests, and/or management report
• Performs Complaint Trending Analyses and participates in Quality Metrics Review and Quality Data Review meetings where complaints are discussed
• Communicates complaint data and relevant clinical information to internal customers in quality, manufacturing and new product development in support of complaint investigations
• Participates in review of/provides clinical guidance for FMEAs (Failure Mode & Effects Analysis) and Risk Management Worksheets
• Provides clinical input to Product Risk Assessments, and participate in Risk Management Councils and Quality Boards
• Aid in response to Regulatory Agencies who inquire about complaint /Risk Management related issues

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Senior