Post-Market Quality Insights Analyst

Mallinckrodt Pharmaceuticals; Bridgewater Township (NJ); Hybrid; USD 61,000 - 98,000; Full time

Benefits offered by this job

Total Rewards package

Job summary

Keenova is seeking a Post Market Surveillance Specialist in Bridgewater, NJ to monitor product performance and support regulatory reporting. You will analyze complaint data, perform trending, and collaborate with R&D, Quality, Operations, and Medical Affairs to ensure compliance across product lifecycles.

The role requires 4+ years in medical device/pharma manufacturing, strong analytical skills, and proficiency in Excel and Power BI. Hybrid/onsite work arrangement with a total rewards package.

Qualifications

• Bachelor's degree in Science, Engineering, Mathematics, Business, or 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.
• Strong analytical, organizational, problem-solving, and time-management skills.
• Advanced proficiency with Microsoft Excel, including pivot tables, formulas, and data analysis; familiarity with Power BI.

Responsibilities

• Perform quality metrics and trending analyses for complaint data.
• Prepare, analyze, and present complaint trending data, product performance metrics, and post-market surveillance information.
• Escalate identified complaint trends, safety signals, or Drug-1 complaints per procedures.
• Complete literature reviews to identify potential product quality complaints or safety information.
• Support product recall activities, including regulatory documentation and reconciliation records.
• Initiate document change controls and update SOPs, WIs, forms, and related quality documents.
• Differentiate and route product quality complaints, adverse events, and regulatory inquiries.
• Capture, review, analyze, and trend product quality data to identify risks and opportunities.
• Comply with global regulations and internal procedures for product experiences reporting.
• Collaborate with cross-functional teams (R&D, Engineering, Quality, Operations, Medical Affairs, etc.).
• Generate and distribute complaint databases, scorecards, dashboards, and surveillance metrics.
• Provide support during audits and regulatory inspections, including responses.
• Support continuous improvement in complaint handling and analytics.
• Perform other duties as assigned.

Skills

Analytical skills

Organizational skills

Problem solving

Time management

Communication skills

Presentation skills

Independent worker

Multitasking

Education

Bachelor's degree in Science, Engineering, Mathematics, Business, or related discipline

Tools

Power BI

Excel

Word

PowerPoint

Job description

Keenova is seeking a Post Market Surveillance Specialist in Bridgewater, NJ to monitor product performance and support regulatory reporting. You will analyze complaint data, perform trending, and collaborate with R&D, Quality, Operations, and Medical Affairs to ensure compliance across product lifecycles.

The role requires 4+ years in medical device/pharma manufacturing, strong analytical skills, and proficiency in Excel and Power BI. Hybrid/onsite work arrangement with a total rewards package.