Client: A leading Pharmaceutical company.
The primary responsibility of this position is the investigation, analysis, resolution, trending of all complaints. Specific responsibilities include; while maintaining the complaint files.
Essential Duties and Responsibilities include the following (other duties may be assigned.):
• Being point of contact with customers and patients.
• Providing excellent customer service and guiding customers and patients through complaint reporting process.
• Day-to-day review of service calls to identify and categorize complaints
• Establishes and maintains complete complaint files for all customer complaints
• Responsible for investigating complaints to resolve both product/procedure issues determined through failure analysis, focusing on root cause analysis
• Reviews and analyzes customer complaint information for trending/risk analysis and corrective action and resultant effectiveness of action
• Interfaces with customer service and technical service and other groups on a daily basis to drive timely completion of complaints
• Will communicate directly with customer to resolve complaints
• Applies systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving complaints
• Maintains compliance to internal complaints procedure, FDA, ISO and Canadian medical device regulations
• Bachelor’s degree in science or other technical discipline or a minimum of 2 years relevant work experience preferred
• Minimum of 1 year of experience in FDA regulated medical device manufacturing environment(s) preferred
• Knowledge of QSR, ISO13485, and ISO14971
• Problem solver.
• Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.