Specialist , Quality Compliance - BD Advanced Patient Monitoring

Becton Dickinson (BD) recently completed the acquisition of the Edwards Critical Care business.  This position is part of the Critical Care division, and as such will become a part of the BD organization in the future.  Critical Care will operate as a separate business unit, called Advanced Patient Monitoring (APM) within BD's medical segment, aligning with BD's smart connected care approach.   BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. If you are invited to interview for this position, a recruiter will provide further details about this exciting transition. Learn more about BD at bd.com    

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; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate 

• Manage customer relationships and expectations during the course of complaint investigation and resolution process 

• Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations 

• Identify problems and lead projects to improve processes, procedures, and/or practices; recommend solutions, including devising new approaches to problems encountered 

• Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA 

• 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 

• Prepare and submit final customer correspondence 

• Assist in planning agendas and running 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 

• Other duties assigned by Leadership (May assist in auditing complaint files) 

What you’ll need (required) 

• Bachelor's Degree in related field plus three years of complaint handling experience and medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment 

What else we look for (preferred): 

• Proven expertise in MS Office Suite and ability to operate general office machinery 

• Excellent written and verbal communication skills and interpersonal relationship skills 

• Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required 

• Demonstrated problem-solving, critical thinking, and investigative skills Ability to build stable working internal/external relationships 

• Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance 

• Good knowledge of medical terms and human anatomy 

• Full knowledge of Medical Device Reporting regulatio