Hiring: Post Market Surveillance Specialist Company: Keenova Location: Bridgewater, NJ Job Posted Time: 2026-09-16 17:45:57 Employment Type: Hybrid Target Skills & Keywords : Microsoft Excel, Microsoft PowerPoint, R About the job Experience: •Minimum 4 years of experience in medical device, biologics, and/or pharmaceutical manufacturing. •Minimum 1 year of experience performing data analysis and trending activities. Required Skills: •Perform quality metrics and trending analyses for complaint data, including complaint timeliness, lot trending, complaint category trending, and root cause trending presented during Product Performance Management and Management Review meetings. •Prepare, analyze, and present complaint trending data, product performance metrics, and post-market surveillance information to support annual drug and device reports. •Escalate identified complaint trends, safety signals, or Drug-1 complaints in accordance with company procedures. •Complete literature reviews to identify potential product quality complaints, adverse events, or safety-related information relevant to marketed products. •Support product recall activities, including preparation of regulatory documentation, maintenance of reconciliation records, and communication with consignees. •Initiate document change controls and support revision of standard operating procedures, work instructions, forms, and related quality documents. •Differentiate and appropriately route product quality complaints, adverse events/incidents, medical information requests, customer feedback, and regulatory agency inquiries. •Capture, review, analyze, and trend product quality complaint data to identify emerging risks and opportunities for continuous improvement. Qualifications: •Bachelor's degree in Science, Engineering, Mathematics, Business, or a related discipline. Compensation: •$61,000 - $98,000 / year •This position is eligible for a bonus in accordance with the terms of the applicable program Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!