Quality Operations Coordinator (61182)

ASP Global, LLC•Mableton, GA

10d•Onsite

About The Position

Coordinator, Quality Systems is a fulltime position that performs day to day quality functions in compliance with ASP Globals Quality Management System. This position supports compliance with FDA 21 CFR 820 through management of inspections, reworks, relabeling and kitting functions.

Requirements

Excellent working knowledge of 21 CFR 820
Strong analytical, problem solving and technical writing skill
The ability to work with a variety of disciplines and levels of staff both internally and externally
Attention to Detail - Thoroughness in accomplishing a task through concern for all the areas involved, no matter how small. Monitors and checks work or information and plans and organizes time and resources efficiently.
Planning & Organizing / Time Management - Establishes a systematic course of action for self or others to ensure accomplishment of a specific objective. Sets priorities, goals, and timetables to achieve maximum productivity.
Collaboration - Develops cooperation and teamwork while participating in a group, working toward solutions which generally benefit all involved parties.
Reliability - Demonstrates a high level of dependability in all aspects of the job.
Bachelor degree, preferably in Life Science, Chemistry or Engineering and 3+ years of experience in a medical device or related industry/organization or 10+ years of quality experience in a medical device or related industry/organization

Responsibilities

Manage Customer Complaint files including but not limited to root cause investigation, customer/field representative communication, supporting the contract manufacturer investigation and timely closure of complaint investigation files.
Perform/coordinate in depth investigations to include root causes for situations identified as NCRs, CAPAs, SCARs or complaints.
Support the Supplier Quality program by managing supplier quality files, including management of the supplier questionnaires.
Generate and distribute periodic quality reports detailing the quality system performance.
Oversee global corporate QMS training program.
Assist in management of quality systems, including reviewing and revision of procedures, forms and other controlled documents.
Maintain Document Control System and update policies and procedures to support continuous improvement and quality objectives.
Maintain accurate Quality filing system and appropriate documentation to conform to quality and GMP regulations.
Ensure containment activities are executed appropriately.
Monitor the customer feedback inbox, ensure pertinent information is distributed appropriately.
Support the customer service team by providing technical documentation when appropriate.
Support rework and relabeling operations when necessary.
Manage the Return Material Authorization process (RMA) in compliance with ASP Global procedures.