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Coordinator

Company: Marquee Staffing
Location: San Clemente
Posted on: May 3, 2021

Job Description:


The Complaint Analyst II & Recall Coordinator is a technical Quality Assurance and Regulatory position that is responsible for receiving, reviewing, and documenting complaint evaluations of all Avante Health Solutions products and services according to FDA, European and Canadian requirements for medical device customer complaints. This position primarily interfaces with the service and operations departments in the identification and resolution of customer complaints. The Complaint Analyst II evaluates each complaint with an understanding of U.S. And International medical device regulations and ensures the proper and timely handling of each complaint



Essential Job Functions & Responsibilities
Establishes and maintains complaint files and databases for all customer complaints, according to U.S. And International regulatory requirements
Investigates all related systems for proper data collection; including, but not limited to, interviewing employees, collecting additional complaint evidence or communicating to customers
Reviews all received complaints to identify whether a complaint is reportable under the Medical Device Reporting (MDR) guidelines in the US or other international system requirements
Maintains all complaint procedures, files and records according to established Avante Health Solutions procedures
Develops and maintains quality metrics for and trending of product complaints, according to the direction of the Quality Manager and Sr. Director of Quality and Regulatory Affairs
Evaluates and analyzes incoming data to ensure proper and immediate action regarding important regulatory requirements
Coordinates with complaint investigation and analysis personnel to understand root cause analysis in support of documentation to properly close the complaint; may interface in specific CAPA s related to selected complaints to provide additional data during CAPA investigations and analysis
Interacts with other functional groups inside and outside the Quality department; works closely with the Regulatory Affairs Group to ensure timely and accurate information is presented for any post-market surveillance and vigilance activities are needed
Assists QA/RA by participating within Complaint Meetings to discuss identified trends and areas for improvement
Possesses excellent interpersonal skills to interact effectively with staff, vendors and guests
Identifies change in processes and offers applications and solutions to promote optimal efficiency



Experience/Training/Education/Competence
2-4 years experience in working as a Complaint Analyst II
Significant experience in the process of medical Device Reporting Determinization, drafting the report and submitting MDR s
Thorough understanding of 21CFR Part 820.198 and Parts 803 and 806.
Customer Service Experience is a plus and can serve as a large portion of the years of experience
Described herein, the FDA Part 820 and ISO 13485: 2016 Quality System Level Experience that is necessary for the role.
o For example; Employee must have 1-3 years experience investigating complaints, compiling the result and closing complaints in accordance with 21 CFR Part 820.198 and ISO13485: 2016.
o Complaint Analyst must have two to five years of experience as Management Representative in an FDA 21CFR Part 820 and ISO13485: 2016 Quality System




Keywords: Marquee Staffing, San Clemente , Coordinator, Other , San Clemente, California

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