Edwards Lifesciences
Senior Quality Compliance Specialist - MDR Reporting
Edwards Lifesciences, California, Missouri, United States, 65018
Employer Industry: Medical Device Manufacturing
Why consider this job opportunity:
Salary up to $113,000 for highly experienced candidates
Opportunity for career advancement and growth within the organization
100% remote work flexibility within the U.S.
Competitive salaries and performance-based incentives
Comprehensive benefits programs to support employees and their families
Chance to make a positive impact on patient safety and product quality
What to Expect
Assess and evaluate global complaint information, conducting investigations as necessary and escalating issues appropriately Prepare and submit Medical Device Reporting (MDR) reports to the FDA Manage customer relationships and expectations during the complaint investigation and resolution process Lead and facilitate weekly meetings to discuss complaint issues with various departments to identify root causes and resolve open action items Analyze and audit complaint data/files and develop reports as needed What is Required
Bachelor's degree plus five (5) years of experience with complaint handling and evaluating complaints for Medical Device Reporting (MDR) Experience in the medical device industry, particularly with cardiovascular, endovascular, or critical care/surgical products Strong knowledge of 21 CFR 820 & 803 regulations Excellent written and verbal communication skills, with strong interpersonal relationship skills Proven problem-solving, critical thinking, and investigative skills How to Stand Out (Preferred Qualifications)
Experience submitting Medical Device Reports Proficient knowledge of medical terms and human anatomy Familiarity with Good Documentation Practices (GDP) related to complaint filing Expertise in MS Office Suite and general office machinery Substantial knowledge of company policies, procedures, and guidelines relevant to quality compliance #MedicalDevices #QualityAssurance #RemoteWork #CareerGrowth #PatientSafety We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
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Assess and evaluate global complaint information, conducting investigations as necessary and escalating issues appropriately Prepare and submit Medical Device Reporting (MDR) reports to the FDA Manage customer relationships and expectations during the complaint investigation and resolution process Lead and facilitate weekly meetings to discuss complaint issues with various departments to identify root causes and resolve open action items Analyze and audit complaint data/files and develop reports as needed What is Required
Bachelor's degree plus five (5) years of experience with complaint handling and evaluating complaints for Medical Device Reporting (MDR) Experience in the medical device industry, particularly with cardiovascular, endovascular, or critical care/surgical products Strong knowledge of 21 CFR 820 & 803 regulations Excellent written and verbal communication skills, with strong interpersonal relationship skills Proven problem-solving, critical thinking, and investigative skills How to Stand Out (Preferred Qualifications)
Experience submitting Medical Device Reports Proficient knowledge of medical terms and human anatomy Familiarity with Good Documentation Practices (GDP) related to complaint filing Expertise in MS Office Suite and general office machinery Substantial knowledge of company policies, procedures, and guidelines relevant to quality compliance #MedicalDevices #QualityAssurance #RemoteWork #CareerGrowth #PatientSafety We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
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