Job Type: Contract
Job Length: 1 Year (Renewable)
Job ID: 9952
- Looking for experience individual who has worked in the medical device industry and who has processed complaint records to meet all regulatory requirements.
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.
• Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which complies