Quality | Post Market Complaint Data Analyst | Orthopedics

Skills Alliance; EE. UU.; Híbrido; USD 80.000 - 120.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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

Responsabilidades

• 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

Conocimientos

Data analysis

Post-market focus

Regulatory awareness

Cross-functional communication

Educación

BS in Biomedical Engineering, Life Sciences or Data Science

Herramientas

Excel

SAS

R

Python

Descripción del empleo

Post Market Complaint Data Analyst | Orthopedics

Hybrid (Florida) or US Remote | $80k - 120k base + bonus + benefits

Complaint handlers find the problems. Engineers fix them. You prove whether the fix worked.

Our client is an orthopedic device manufacturer is building out its post-market team, and this analyst seat sits at the center of it. You’ll report to the Senior Director and work every day with complaint handlers and investigation engineers. Your data will drive root cause, CAPA and regulatory decisions, not just fill a database.

What you’ll own

• Complaint data from intake to insight: collecting, cleaning, analyzing and keeping it audit-ready
• The tracking and trending the team runs on, including Excel pivots, charts and dashboards
• Data for international vigilance submissions, mainly EU MIRs under EU MDR
• Your seat at trending reviews, root cause investigations and CAPA discussions
• Clear, defensible reports for Quality, Regulatory, R&D and external stakeholders

What you’ll bring

• 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 sets you apart
• A BS in Biomedical Engineering, Life Sciences, Data Science or similar, or equivalent experience

Why this one

A growing team where your work is visible to senior leadership, real exposure to global vigilance, and a clear path into broader post-market quality roles.