What are the responsibilities and job description for the Post-Market Surveillance Analyst position at ProKatchers LLC?
Job Title : Post-Market Surveillance Analyst
Location : Marlborough, MA 01752
Duration : 06 Months
Shift Details : Regular / On-Site
Job Description :
- Lead a Complaint Handling Unit (CHU) supporting and executing the triage, investigation, and closure of product quality complaints.
- Tasks include coordinating and supporting investigations, running trend reports, performing statistical analysis of trends, tracking major issues and related corrective actions, assisting in final customer reports, and interfacing with customers in various forms of communications.
- Facilitate risk-assessment activities and acts as QA lead for Field Actions involving Aseptic Filling product groups
- Bachelor's degree in Biological Sciences, engineering, or related field (e.g., Biomedical Engineering, Systems Engineering, Pharmacology, Chemistry) or equivalent work experience
Experience in a regulated environment such as medical devices (ISO 13485), pharmaceuticals (GMP), or biotechnology.
Proficiency with quality management systems (QMS) and tools like Veeva, TrackWise, Salesforce, Magic.