Edwards Lifesciences
Senior Quality Compliance Specialist - MDR Reporting
Edwards Lifesciences, Granite Heights, Wisconsin, United States
Overview
Employer Industry: Medical Devices Salary up to $113,000 for highly experienced candidates Opportunity for career advancement and growth within the organization Work remotely anywhere within the U.S. Competitive salaries and performance-based incentives Comprehensive benefits programs to support employees and their families Chance to make a significant impact on patient safety and product quality What to Expect (Job Responsibilities)
Assess and investigate global complaint information, escalating as appropriate Evaluate complaints for Medical Device Reporting (MDR) and prepare reports for FDA submission Identify problems and lead projects to improve complaint handling processes and procedures Manage customer relationships and expectations throughout the complaint investigation process Lead weekly meetings to discuss complaint issues with various departments and resolve open action items What is Required (Qualifications)
Bachelor’s degree plus five (5) years of experience in complaint handling and evaluating complaints for MDR Experience in the medical device, healthcare, or related industries Proven knowledge of Good Documentation Practices (GDP) and familiarity with 21 CFR 820 & 803 regulations Excellent written and verbal communication skills Ability to manage confidential information with discretion How to Stand Out (Preferred Qualifications)
Experience submitting Medical Device Reports Proficient knowledge of medical terms and human anatomy Strong problem-solving, critical thinking, and investigative skills Substantial knowledge of policies, procedures, and guidelines relevant to quality compliance Proven expertise in MS Office Suite and general office machinery operation #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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Employer Industry: Medical Devices Salary up to $113,000 for highly experienced candidates Opportunity for career advancement and growth within the organization Work remotely anywhere within the U.S. Competitive salaries and performance-based incentives Comprehensive benefits programs to support employees and their families Chance to make a significant impact on patient safety and product quality What to Expect (Job Responsibilities)
Assess and investigate global complaint information, escalating as appropriate Evaluate complaints for Medical Device Reporting (MDR) and prepare reports for FDA submission Identify problems and lead projects to improve complaint handling processes and procedures Manage customer relationships and expectations throughout the complaint investigation process Lead weekly meetings to discuss complaint issues with various departments and resolve open action items What is Required (Qualifications)
Bachelor’s degree plus five (5) years of experience in complaint handling and evaluating complaints for MDR Experience in the medical device, healthcare, or related industries Proven knowledge of Good Documentation Practices (GDP) and familiarity with 21 CFR 820 & 803 regulations Excellent written and verbal communication skills Ability to manage confidential information with discretion How to Stand Out (Preferred Qualifications)
Experience submitting Medical Device Reports Proficient knowledge of medical terms and human anatomy Strong problem-solving, critical thinking, and investigative skills Substantial knowledge of policies, procedures, and guidelines relevant to quality compliance Proven expertise in MS Office Suite and general office machinery operation #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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