What are the responsibilities and job description for the Medical Device Complaint Analyst position at Novozen Healthcare LLC?
Job title: Medical Device Complaint Analyst
Location: Newark, Delaware
Employment Type: W2 Only
Duration: 12 Months
Job Summary
We are seeking a technically strong Medical Device Complaint Analyst to support complaint investigations related to biopsy and mammography systems. The ideal candidate should have solid experience working with complex electromechanical medical devices and be capable of analyzing complaint trends, troubleshooting product failures, and identifying root causes beyond documentation review.
This role will work closely with Quality, Manufacturing, and PMQA teams to investigate installation and field complaints, support CAPA activities, and improve product reliability.
Key Responsibilities
- Review and investigate installation and customer complaints for biopsy, mammography, and other complex electromechanical medical devices
- Analyze complaint data, NCRs, and recurring failure trends to identify systemic issues
- Troubleshoot mechanical and electrical failures to determine root cause
- Support CAPA investigations and corrective/preventive action activities
- Collaborate with Manufacturing, Quality, and PMQA teams on product failure investigations
- Work directly with operators and manufacturing personnel to understand assembly processes and equipment behavior
- Identify escalation risks and failure modes through technical analysis and hands-on investigation
- Support complaint trending and ensure proper issue categorization/documentation
- Participate in continuous improvement initiatives related to product quality and reliability
Required Qualifications
- 4 years of experience in complaint handling, complaint analysis, product quality, or post-market quality within medical devices
- Strong troubleshooting skills involving electromechanical systems
- Experience conducting root cause investigations, NCR analysis, and CAPA support activities
- Ability to analyze complaint trends and identify recurring/systemic failures
- Good understanding of manufacturing processes and complex assemblies
- Experience working in regulated medical device environments
Preferred Qualifications
- Experience with biopsy systems, mammography systems, imaging devices, or capital equipment
- Background in Manufacturing Engineering, Product Quality, or Complaint Investigation
- Familiarity with FDA regulations and ISO 13485 standards
- Hands-on experience supporting manufacturing investigations or field issue resolution
Salary
The hourly rate for this position is $45 – $55 per hour ( DOE )
Benefits
This is a contract position and does not include employer-provided benefits.
Equal Opportunity Employer
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Background Check
Background checks may be conducted in accordance with applicable laws
Work Authorization
Applicants must be authorized to work in the United States
Salary : $45 - $55