Post‑Market Surveillance Analyst — Data & Trends

Keenova

Bridgewater (MA)

Hybrid

USD 61,000 - 98,000

Full time

44 hours ago

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Job summary

Keenova is seeking a Post Market Surveillance Specialist to support product monitoring and post‑market activities across the product lifecycle. You will analyze complaint data, develop dashboards, and collaborate with R&D, Quality, Operations, and Medical Affairs to drive continuous improvement.

The role requires a Bachelor's degree in a relevant field and 4+ years in medical device/pharma environments, with expertise in Excel and Power BI.

Qualifications

Bachelor's degree in Science, Engineering, Mathematics, Business, or a related discipline.
Minimum 4 years of experience in medical device, biologics, and/or pharmaceutical manufacturing.
Minimum 1 year of experience performing data analysis and trending activities.
Experience with complaint management and post‑market surveillance preferred.

Responsibilities

Perform quality metrics and trending analyses for complaint data and product performance.
Prepare, analyze, and present complaint trending data for regulatory reports.
Escalate identified trends or safety signals according to procedures.
Complete literature reviews to identify potential quality complaints or safety information.
Support product recalls, including regulatory documentation and reconciliation records.
Initiate document change controls and revise quality documents as needed.
Differentiate and route product quality complaints, adverse events, inquiries, and feedback.
Capture and trend data to identify risks and opportunities for improvement.
Ensure compliance with global regulations and internal procedures for reporting.
Collaborate with cross‑functional teams to evaluate complaint data and performance.
Generate, maintain, and distribute complaint reports and dashboards.
Support internal/external audits and regulatory inspections with metrics and responses.
Assist in continuous improvement initiatives related to complaints and surveillance.