April 10, 2019
QA COMPLAINT SPECIALIST ASSOCIATE
About The Opportunity
- The primary responsibility of this position is the investigation, analysis, resolution, trending and corrective action of all complaints.
- Specific responsibilities include; maintaining the complaint files and supporting the resolution of complaint CAPAs to closure and verification of CAPA effectiveness.
- Essential Duties and Responsibilities include the following (other duties may be assigned.):
- 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
- May 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
- Bachelors 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. Additional Requirements:
- 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 ZELTIQ complies.
Please Contact me to discuss the hiring process!
Sr. Executive Recruiter
Contact: (310) 929-8421 Ext: 108
Hi! My name is Harmanpreet Singh. I love to work with people and help them find their dream job. I work with my consultants to understand their niche area of work and look for the best match for them. I feel that keeping in mind the priorities of my consultants help me to serve them better. Additionally, I always keep them posted about new relevant jobs which help me to build a connection with them not only professionally but at a personal level as well.