Quality Compliance Specialist

Job Title Job Overview: Pay Range: $35.97hr - $40.97hr Responsibilities Manage customer relationships and expectations throughout the complaint investigation and resolution process. Conduct detailed investigations by collaborating with Product Safety, Engineering, and cross-functional teams. Evaluate complaints for Medical Device Reporting (MDR) requirements and prepare submissions to regulatory authorities. Analyze product issues, including imaging, product performance, IFU, and related documentation to determine root cause. Summarize investigation findings and prepare clear, comprehensive reports and customer communications. Lead process improvement initiatives to enhance complaint handling procedures and quality practices. Facilitate cross-functional meetings to review complaint trends, assign root causes, and track action items. Ensure compliance with regulatory requirements and internal quality standards. Qualifications Bachelor's degree in a related field or equivalent experience. 2–4 years of experience in medical device, healthcare, or regulated industry environments. Strong understanding of Medical Device Reporting (MDR) regulations and quality compliance standards. Knowledge of medical terminology and human anatomy. Experience with complaint handling, investigations, and root cause analysis. Proficiency in Microsoft Office Suite and general office tools. Skills Excellent written and verbal communication skills. Strong analytical, problem-solving, and investigative abilities. Ability to manage multiple priorities in a fast-paced environment. High attention to detail and strong documentation practices. Ability to work independently and collaborate with cross-functional teams. Strong interpersonal skills with the ability to interact across all organizational levels. Education Bachelor's Degree in a related field.