Complaint Evaluation Specialist
Advantage Technical, Acton, MA, United States
Complaint Evaluation Specialist (Medical Device) - Contract
Location:
Acton
Pay Rate:
Up to $34.00/hr.
We are hiring a detail-oriented Complaint Evaluation Specialist to support a leading medical device organization. The contract role focuses on complaint handling, data analysis, and regulatory compliance, ensuring product quality and patient safety.
Key Responsibilities
Manage the full complaint lifecycle: intake, investigation, documentation, and closure.
Perform reportability assessments in line with FDA and ISO regulations.
Analyze complaint trends, generate reports, and support data-driven decisions.
Review Device History Records (DHRs) to identify product issues or anomalies.
Support adverse event investigations and basic failure analysis.
Maintain accurate records for complaints, audits, and special projects.
Assist with FDA, ISO, and internal audits.
Coordinate with cross-functional teams including Quality, Customer Care, and Engineering.
Train team members on complaint handling processes and systems.
Qualifications
Bachelor's degree OR 3+ years of experience in medical device complaint handling or vigilance reporting.
1-2+ years of experience in data management, documentation, or quality systems.
Strong understanding of regulatory standards (FDA, ISO, cGMP) preferred.
Excellent analytical, organizational, and problem-solving skills.
Strong technical writing and communication abilities.
Proficiency in Microsoft Office and database systems.
Employee Benefits
Medical, dental, vision, and pet insurance.
401(k) Retirement Savings Plans.
Employee Assistance Program (EAP).
Commuter/Parking Accounts.
People Perks.
Health Savings Account (HSA).
AD & D Insurance.
Equal Opportunity Employer
Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries.
Advantage Technical is an E-Verify employer. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.
See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors.
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Location:
Acton
Pay Rate:
Up to $34.00/hr.
We are hiring a detail-oriented Complaint Evaluation Specialist to support a leading medical device organization. The contract role focuses on complaint handling, data analysis, and regulatory compliance, ensuring product quality and patient safety.
Key Responsibilities
Manage the full complaint lifecycle: intake, investigation, documentation, and closure.
Perform reportability assessments in line with FDA and ISO regulations.
Analyze complaint trends, generate reports, and support data-driven decisions.
Review Device History Records (DHRs) to identify product issues or anomalies.
Support adverse event investigations and basic failure analysis.
Maintain accurate records for complaints, audits, and special projects.
Assist with FDA, ISO, and internal audits.
Coordinate with cross-functional teams including Quality, Customer Care, and Engineering.
Train team members on complaint handling processes and systems.
Qualifications
Bachelor's degree OR 3+ years of experience in medical device complaint handling or vigilance reporting.
1-2+ years of experience in data management, documentation, or quality systems.
Strong understanding of regulatory standards (FDA, ISO, cGMP) preferred.
Excellent analytical, organizational, and problem-solving skills.
Strong technical writing and communication abilities.
Proficiency in Microsoft Office and database systems.
Employee Benefits
Medical, dental, vision, and pet insurance.
401(k) Retirement Savings Plans.
Employee Assistance Program (EAP).
Commuter/Parking Accounts.
People Perks.
Health Savings Account (HSA).
AD & D Insurance.
Equal Opportunity Employer
Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries.
Advantage Technical is an E-Verify employer. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.
See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors.
#J-18808-Ljbffr