Senior Lead Quality Analyst - Post Market Surveillance

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Senior Lead Quality Analyst - Post Market Surveillance
Fully Remote

Description

Summary of the Position

The Sr. Lead Quality Analyst – Post Market Surveillance (PMS) supports the Complaint Manager in managing, coordinating, and continuously improving global complaint handling and post-market surveillance processes for the WiSE CRT System and associated components.

This individual acts as a Subject Matter Expert (SME) for complaint investigations, root‑cause analysis, and complaint related CAPA’s, ensuring that technical findings are translated into clear, accurate, and meaningful summaries for regulatory audiences.

The role requires strong clinical judgment to assess event severity and reportability under FDA (21 CFR 803/820), EU MDR 2017/745, TGA (Australia), and PMDA (Japan) regulations. A Nursing degree is required, along with in‑depth knowledge of cardiolo...