Complaint Investigator

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Requirements:

• Bachelor's degree in Biological Sciences or related field
• 3 years of related experience in medical device post-market product surveillance and complaint handling.
• Strong analytical and problem-solving skills, with 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.
• Experience with SAP is preferred.
• Proficiency in Microsoft Office Products (Word, Excel, PowerPoint) or equivalent software applications is preferred.
• 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.