Edwards Lifesciences
Senior Quality Compliance Specialist - MDR Reporting
Edwards Lifesciences, Chicago, Illinois, United States
Overview
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
Work remotely anywhere within the U.S.
Competitive salary and performance-based incentives
Comprehensive benefits programs to support employees and their families
Chance to impact patient care through innovative technology
Responsibilities
Assess and evaluate global complaint information, conducting further investigations as necessary
Prepare and submit Medical Device Reporting (MDR) reports to the FDA
Lead projects to enhance processes and resolve issues related to complaint handling
Manage customer relationships during complaint investigations and resolutions
Summarize findings from investigations, including product analysis and relevant documentation
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 industry, specifically with cardiovascular or surgical products
Strong knowledge of 21 CFR 820 & 803 regulations
Excellent written and verbal communication skills
Proven problem-solving and investigative skills
Preferred Qualifications
Experience submitting Medical Device Reports
Proficient knowledge of medical terminology and human anatomy
Familiarity with Good Documentation Practices (GDP) related to complaint filing
Expertise in MS Office Suite and general office machinery operation
Understanding of company policies relevant to quality compliance
#MedicalDevices #QualityAssurance #RemoteWork #CareerGrowth #HealthcareInnovation
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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Why consider this job opportunity:
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 salary and performance-based incentives
Comprehensive benefits programs to support employees and their families
Chance to impact patient care through innovative technology
Responsibilities
Assess and evaluate global complaint information, conducting further investigations as necessary
Prepare and submit Medical Device Reporting (MDR) reports to the FDA
Lead projects to enhance processes and resolve issues related to complaint handling
Manage customer relationships during complaint investigations and resolutions
Summarize findings from investigations, including product analysis and relevant documentation
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 industry, specifically with cardiovascular or surgical products
Strong knowledge of 21 CFR 820 & 803 regulations
Excellent written and verbal communication skills
Proven problem-solving and investigative skills
Preferred Qualifications
Experience submitting Medical Device Reports
Proficient knowledge of medical terminology and human anatomy
Familiarity with Good Documentation Practices (GDP) related to complaint filing
Expertise in MS Office Suite and general office machinery operation
Understanding of company policies relevant to quality compliance
#MedicalDevices #QualityAssurance #RemoteWork #CareerGrowth #HealthcareInnovation
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.
#J-18808-Ljbffr