Complaint Investigator

Complaint Investigator

Requirements

• Bachelor’s degree in Biological Sciences or related field (e.g., Biomedical Engineering, Systems Engineering, Pharmacology, Chemistry)
• 3 years of related experience in medical device post-market product surveillance and complaint handling
• Strong analytical and problem-solving skills
• Excellent written and verbal communication abilities
• Proficient in data analysis and workflow troubleshooting, including instrumentation, arrays, and biological materials
• Proven ability to manage and prioritize workload, meet deadlines, and work effectively in a dynamic environment
• Exceptional organizational skills and attention to detail
• Familiarity with ISO 13485, 21 CFR 820, 21 CFR 803, and QSR quality management system requirements and IVD products

Responsibilities

• Review service records to identify product issues related to medical device/IVD quality complaints
• Document comprehensive and accurate findings for each complaint investigation, including reportability assessment, root cause, conclusions, and corrective actions in compliance with regulatory requirements
• Communicate and escalate investigation results and facilitate the decision-making process for failure investigations
• Collaborate with cross-functional teams, including R&D, Quality, Manufacturing, Support and Service, Logistics, Regulatory Affairs, and Medical Affairs, to address product safety and quality issues
• Support quality system investigations, including nonconformances, corrective actions, and preventive actions
• Update and maintain complaint investigation procedures to ensure alignment with current standards and best practices
• Conduct and facilitate product and process training sessions to enhance team competency
• Participate in the analysis, tracking, and trending of complaints data for Global Quality and Regulatory Affairs meetings on a weekly and monthly basis and drive quality improvements
• Provide support for global and local audits and inspections, ensuring compliance with regulatory standards and organizational requirements

Preferred Qualifications

• Experience with SAP is preferred
• Proficiency in Microsoft Office Products (Word, Excel, PowerPoint) or equivalent software applications is preferred