ASP Global · 23 hours ago
Quality Operations Coordinator (61182)
AUSTELL, GA 30168
Full-time
Onsite
Mid, Senior Level
3+ years expASP Global is a company focused on quality management in the medical device industry. The Quality Operations Coordinator will perform day-to-day quality functions in compliance with the company's Quality Management System, manage customer complaints, and support supplier quality programs.
Medical
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
Qualification
Required
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
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
Company
ASP Global
ASP Global is a privately held, Atlanta-based company with additional operations in the Pacific Rim.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Incline Equity Partners
2024-08-06Acquired
2020-02-11Private Equity
Leadership Team
Doug Shaver
Chief Executive Officer
Justin Martin
Chief Product Officer & General Manager, Injury Prevention
Recent News
2023-06-13
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