Senior Complaint Specialist

What You’ll Do

• Ensure global complaint handling activities comply with ISO, FDA, EU MDR 2017/745, and MDSAP requirements.
• Manage the full lifecycle of medical device complaints, including intake, evaluation, investigation, regulatory reporting, resolution, and closure, while ensuring compliance, timely execution, and high-quality documentation.
• Serve as a subject matter expert in complaint handling, medical device reporting, and post-market quality systems.
• Manage the end-to-end lifecycle of global customer complaints across multiple sites, ensuring compliance with applicable regulatory requirements and internal procedures.
• Perform complaint intake, assessment, investigation, resolution, and final customer communication for medical device and product quality issues.
• Evaluate complaints for Medical Device Reporting (MDR) and determine reporting requirements in accordance with FDA, ISO, and global regulatory expectations.
• Conduct root cause analyses, lead complaint investigations, and prepare detailed, high-quality investigation reports.
• Utilize complaint management systems to document, track, trend, and report complaint data and quality metrics.
• Monitor complaint trends and escalate potential quality or safety signals to management for timely action.
• Support Post Market Surveillance activities, including data collection, trending analysis, and regulatory reporting inputs.
• Collaborate with internal and external stakeholders (e.g., clinical sites, physicians, hospitals, sales representatives, and suppliers) to gather complaint-related information.
• Aid in the development and maintenance of complaint metrics, dashboards, and management reporting.
• Support CAPA and Change Control processes, including investigation support, documentation, and effectiveness verification.
• Ensure integration of risk management principles in accordance with ISO 14971 and alignment with design and process controls.
• Participate in internal and external audits as a subject matter expert in complaint handling processes.
• Support continuous improvement initiatives for the global complaint handling and post-market quality systems.
• Maintain accurate complaint files and ensure compliance with good documentation practices (GDP).
• Serve as a trainer and SME for complaint handling processes within the Quality organization.
• Perform other duties and projects as assigned.

What It Takes

• Analyze complex product quality issues across multiple global sites, determine regulatory reporting obligations, and ensure compliance with FDA, ISO, and EU MDR requirements.
• Determine product risk and patient safety implications through strong analytical and problem-solving skills.
• Interpret technical and clinical data with the ability to make sound decisions.
• Work independently, manage competing priorities, and deliver results on time.
• Communicate effectively both verbally and in writing, producing clear, compliant technical reports.
• Use Microsoft Office tools, including spreadsheets and databases.
• Knowledge of statistical process control (SPC) methods and techniques, and working knowledge of Six Sigma methodologies is a plus.
• Experience supporting global post-market surveillance systems and reporting frameworks is a plus.