Quality Compliance Specialist, Complaint Handling – MDR Reporting
Edwards Lifesciences
full-time
Posted on:
Location Type: Remote
Location: Arizona • California • United States
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Salary
💰 $68,000 - $96,000 per year
About the role
- Evaluate global complaint information provided and conduct additional investigation as needed and escalate as appropriate
- Prepare and submit MDR reports to FDA
- Process complaint files from initiation to closure
- Fulfill FDA, ISO and other relevant requirements for designated complaint handling unit
- Manage customer relationship and expectations during course of complaint investigation and resolution process
- Lead and plan agenda for and run weekly meetings to discuss complaint issues with affected functions
Requirements
- Bachelor's degree plus three (3) years of experience with complaint handling and evaluating complaints for MDR (Medical Device Reporting)
- Medical Device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment/industry experience.
- Experience submitting Medical Device Reports
- Proficient knowledge of medical terms and human anatomy
- Good knowledge of Good Documentation Practices (GDP)
- Strong knowledge and familiarity with 21 CFR 820 & 803 regulations
- Proven expertise in MS Office Suite and ability to operate general office machinery
- Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
- Demonstrated problem-solving, critical thinking, and investigative skills
Benefits
- Competitive salaries
- Performance-based incentives
- Wide variety of benefits programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
complaint handlingMedical Device Reporting (MDR)Good Documentation Practices (GDP)21 CFR 820 regulations21 CFR 803 regulationsmedical terminologyhuman anatomyproblem-solvingcritical thinkinginvestigative skills
Soft Skills
written communicationverbal communicationinterpersonal skillsrelationship managementconsultative skills
Certifications
Bachelor's degree