Remote Post-Market Data Analyst: Quality & CAPA Insights

Skills Alliance; United States; Hybrid; USD 80,000 - 120,000; Full time

Job summary

Skills Alliance is seeking a Post Market Complaint Data Analyst for Orthopedics. This hybrid role in Florida or US remote centers on transforming complaint data into actionable insights to guide CAPA, regulatory decisions and root-cause analysis.

You will work closely with complaint handlers and investigation engineers, report to the Senior Director, and influence quality and regulatory outcomes with defensible data-driven reports.

Qualifications

• 2+ years of data analysis in medical device, pharma or biotech
• 2+ years in post-market complaint handling, investigation or analysis
• Strong Excel skills; SAS, R or Python are a bonus
• Working knowledge of FDA 21 CFR 820/803 and ISO 13485; EU MDR vigilance exposure is a plus
• BS in Biomedical Engineering, Life Sciences, Data Science or similar, or equivalent experience

Responsibilities

• Collect, clean and analyze complaint data from intake to insight; keep it audit-ready
• Create and maintain tracking dashboards and charts in Excel
• Provide data for international vigilance submissions, especially EU MIRs under EU MDR
• Contribute to trending reviews, root cause investigations and CAPA discussions
• Prepare clear, defensible reports for Quality, Regulatory, R&D and external stakeholders

Skills

Data analysis

Post-market focus

Regulatory awareness

Cross-functional communication

Education

BS in Biomedical Engineering, Life Sciences or Data Science

Tools

Excel

SAS

R

Python

Job description

Skills Alliance is seeking a Post Market Complaint Data Analyst for Orthopedics. This hybrid role in Florida or US remote centers on transforming complaint data into actionable insights to guide CAPA, regulatory decisions and root-cause analysis.

You will work closely with complaint handlers and investigation engineers, report to the Senior Director, and influence quality and regulatory outcomes with defensible data-driven reports.