COMPLAINT HANDLING ASSOCIATE Project Description:
The primary responsibility of this position is the investigation, analysis, resolution, trending of all complaints. Specific responsibilities include; while maintaining the complaint files.
- 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.
- 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 Client complies.
- 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.
This 12+month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Krysty: URL blocked - click to apply
ALPHA'S REQUIREMENT #19-02002
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
Complex Problem Solving