Sr. Quality Complaint Specialist

The Senior Quality Complaint Specialist’s primary function is analyzing and acting on information from complaint investigations. Additionally, this role develops and implements processes and procedures that drive and ensure compliance with US and International requirements and is responsible for managing and monitoring the status of requests and tasks associated with quality compliance projects.

• Communicate directly with notified body, internal/external customers, distributors, physicians, suppliers, and other manufacturers to ensure timely completion of activities related to complaint and failure investigations.
• Analyze post-production data for compliance with U.S. and international regulations and requirements (ISO 13485, 14971, etc.).
• Execute timely evaluation and submission of reportable product complaints and adverse events to regulatory authorities (e.g. FDA, Health Canada, TGA).
• Responsible for staying current on applicable regulations and incorporating any changes into policies and procedures.
• Investigate product complaints and adverse events to determine root cause and the need for corrective action.
• Maintain electronic quality management system/software for post-market surveillance to collect, monitor and trend data within areas of responsibility.
• Other duties as assigned
• Uphold the highest ethical standards by doing our job compliantly, ethically, and in a manner that reflects our underlying values.
• Monitor assigned projects and tasks to ensure compliance with regulatory agencies, protocols, agreements, and applicable corporate compliance requirements.
• Ensure that policies and procedures comply with domestic, international and corporate standards.

• A broad understanding of regulatory and compliance issues that drive the medical device industry, including those outside of the area of his/her expertise.
• Bachelor degree in biology, health sciences, engineering, nursing or other related discipline with a minimum 5 years’ experience in complaint handling and adverse event reporting.
• Must possess good verbal and written communication skills with an investigative mindset and critical analysis skills.
• Strong knowledge of quality system regulations (FDA QSR, ISO 13485).