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.
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. Code complaint information according to procedures. Assess incoming documentation, including clinical forms and medical information, for complaint data and ascertain compliance to product specification and/or intended use as indicated in the product labeling. Evaluate internal and external lab analysis. Coordinate with inter- and intra-departmental customers to ensure complaints and inquiries across product lines are managed appropriately. Initiate Further Investigation and any additional follow-up and communication pertinent to the MDR as needed. Track files sent to Quality Assurance for further investigation and complete necessary documentation. Evaluate results, summarize findings, and determine and document the conclusion(s). Assist Supervisors and Manager in monitoring complaint and claims workflow to ensure compliance and customer service. Assist in resolving issues by responding to inquiries and answering technical questions regarding product line.
Bachelor's degree with one to two years previous experience in customer service or clinical setting or equivalent combination of education and experience. Customer service experience. Familiarity with Regulations pertaining to devices/510K (i.e. FDA, MHRA, etc.) Flexibility in managing multiple tasks and expectations.
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Product Surveillance Tech I (Medical device) • Great Lakes, IL, United States
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