Post-Market Quality & Data Analytics Lead

Mallinckrodt Pharmaceuticals; United States; Hybrid; USD 61,000 - 98,000; Full time

Benefits offered by this job

Total Rewards package

Bonus program

Job summary

Keenova is seeking a Post Market Surveillance Specialist in Bridgewater, NJ. You will monitor, analyze, and report on product quality and performance data, perform complaint trending, literature reviews, and support regulatory reporting to ensure compliance with global quality system requirements.

The role collaborates with cross-functional teams (R&D, Engineering, Quality, Operations, Medical Affairs, and Customer Care) to identify trends and drive continuous improvement throughout the product

Qualifications

• Bachelor's degree in Science, Engineering, Mathematics, Business, or related discipline.
• Minimum 4 years in medical device, biologics, and/or pharmaceutical manufacturing.
• Minimum 1 year in data analysis and trending activities.

Responsibilities

• Perform quality metrics and trending analyses for complaint data and product performance.
• Prepare, analyze, and present complaint trending data for regulatory reporting.
• Escalate safety signals and regulatory concerns per procedures.
• Support literature reviews and recall activities; assist with SOP revisions.

Skills

Excel

Power BI

Word

PowerPoint

Data analysis

Regulatory knowledge

Education

Bachelor's degree in Science/Engineering/Mathematics

Tools

Microsoft Excel

Power BI

Job description

Keenova is seeking a Post Market Surveillance Specialist in Bridgewater, NJ. You will monitor, analyze, and report on product quality and performance data, perform complaint trending, literature reviews, and support regulatory reporting to ensure compliance with global quality system requirements.

The role collaborates with cross-functional teams (R&D, Engineering, Quality, Operations, Medical Affairs, and Customer Care) to identify trends and drive continuous improvement throughout the product