Job Description
North Chicago, IL Contract JOB SUMMARY: Under general direction, the Post Market Quality Assurance (PMQA) Analyst I will investigate and maintain complaint files, in compliance with regulations established by the FDA and international regulatory bodies, and submit safety reports to the FDA and international Competent Authorities. In addition will process claims for financial reimbursement and replacement products in accordance with reimbursement policy. Act as a key resource within the department by mentoring Representatives, monitoring complaints and providing ongoing coaching and training. The PMQA Analyst is a subject matter expert due to demonstrated excellence in work performance and mastery of the knowledge, tasks, and skill sets. Provides technical and administrative support to internal and external customers. " The candidate must conduct their work activities in compliance with all internal requirements and with all applicable regulatory requirements, including knowledge of operating in a controlled environment per the requirements of 21 CFR 820, ISO 13485 and ISO 14971. Requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives. KEY DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE: Initiate, investigate, and maintain complaint files following complaint handling regulation 21 CFR 820.198 and internal procedures. Analyze information obtained and make follow up calls to reporters. Initiate and set up complaint files. Maintain and update database. Record all complaint activity in both hard copy (when applicable) and computer files. C