Manager, Product Quality Clinician (Cath Lab / IR / CVOR Registered Nurse)

**This position offers the flexibility of being either fully remote or hybrid remote, but the selected candidate must be residing within the United States.

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 Qualifications):  

• Bachelor’s degree required (nursing or related discipline preferred). Will consider a combination of education and related work experience as a substitute for a bachelor’s degree. 
• Minimum of 8 years of hospital/clinical experience
• Current or prior Registered Nurse (RN)

What else we look for (Preferred Qualifications):

• Cath Lab, Cardiac Care, ICU, Operating Room, or Cardiovascular/Endovascular interventions experience (Cath Lab experience highly preferred) 
• Experience in the medical device industry
• Experience leading teams 
• Excellent written and oral English communication 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) and routine correspondence 
• Ability to speak effectively