Edwards Lifesciences
Senior Quality Compliance Specialist - MDR Reporting
Edwards Lifesciences, Saint Paul, Minnesota, 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, offering flexibility within the U.S.
Competitive salaries and performance-based incentives
Comprehensive benefits programs to support diverse employee needs
Chance to contribute to groundbreaking technologies that impact patient lives
What to Expect (Job Responsibilities)
Assess and investigate complaint information, escalating as necessary
Evaluate complaints for Medical Device Reporting (MDR) and prepare submissions to the FDA
Identify problems and lead projects to improve processes and resolve solutions
Manage customer relationships during the complaint investigation and resolution process
Lead weekly meetings to discuss complaint issues with cross-functional teams
What is Required (Qualifications)
Bachelor's degree plus five (5) years of experience with complaint handling and MDR evaluations
Experience in the medical device industry, particularly with cardiovascular or critical care products
Proficient knowledge of medical terms and human anatomy
Strong understanding of 21 CFR 820 & 803 regulations
Excellent written and verbal communication skills
How to Stand Out (Preferred Qualifications)
Experience submitting Medical Device Reports
Good knowledge of Good Documentation Practices (GDP) related to complaint filing
Proven expertise in MS Office Suite and general office machinery
Demonstrated problem-solving, critical thinking, and investigative skills
Substantial knowledge of policies, procedures, and guidelines relevant to quality compliance
#MedicalDevices #QualityAssurance #RemoteWork #CareerGrowth #HealthcareIndustry
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, offering flexibility within the U.S.
Competitive salaries and performance-based incentives
Comprehensive benefits programs to support diverse employee needs
Chance to contribute to groundbreaking technologies that impact patient lives
What to Expect (Job Responsibilities)
Assess and investigate complaint information, escalating as necessary
Evaluate complaints for Medical Device Reporting (MDR) and prepare submissions to the FDA
Identify problems and lead projects to improve processes and resolve solutions
Manage customer relationships during the complaint investigation and resolution process
Lead weekly meetings to discuss complaint issues with cross-functional teams
What is Required (Qualifications)
Bachelor's degree plus five (5) years of experience with complaint handling and MDR evaluations
Experience in the medical device industry, particularly with cardiovascular or critical care products
Proficient knowledge of medical terms and human anatomy
Strong understanding of 21 CFR 820 & 803 regulations
Excellent written and verbal communication skills
How to Stand Out (Preferred Qualifications)
Experience submitting Medical Device Reports
Good knowledge of Good Documentation Practices (GDP) related to complaint filing
Proven expertise in MS Office Suite and general office machinery
Demonstrated problem-solving, critical thinking, and investigative skills
Substantial knowledge of policies, procedures, and guidelines relevant to quality compliance
#MedicalDevices #QualityAssurance #RemoteWork #CareerGrowth #HealthcareIndustry
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