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

Manager, Product Quality Clinician

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.

As a Manager, Product Quality Clinician, 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.

How you will make an impact:

• 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 THV (Transcatheter Heart Valve) 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

What you'll need (Required):

• Bachelor's degree plus 8 years of relevant experience or equivalent work experience based on Edwards' criteria
• Current or previous Registered Nurse (RN) - active license not required
• Cardiac patient care experience (e.g., Telemetry, Step-Down ICU, Treadmill lab, Cardiac Rehab Floor, Heart Failure units, Cardiac Recovery, or similar)
• Medical device industry experience in Quality/Compliance, with a strong preference for complaint handling, complaint investigation, and/or post-market surveillance

What else we look for (Preferred):

• RN with Cath Lab, CVOR, or CVICU nursing experience
• Experience leading cross-functional teams
• Ability to read and interpret documents such as Product Instructions for Use, Training and Procedure Manuals
• Ability to write routine MDR (Medical Device Reports) 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
• Experience training groups
• Knowledge of computer application programs including Excel, PowerPoint and Word
• Excellent written and oral English communication skills

Aligning 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.For California (CA), the base pay range for this position is $126,000 to $178,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., 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 Requirement

Edwards 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.