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Quality Compliance Specialist

Mermaid Medical Group

Mermaid Medical is looking for a Quality Compliance Specialist to support and coordinate key Quality Management System (QMS) activities related to medical device design and manufacturing. You will play a central role in maintaining quality records, supporting compliance processes, and ensuring the effective operation of our electronic quality system (e-QMS). This position is based in Sarasota, FL and reports to the Director of Quality & Regulatory Affairs . Tasks and Responsibilities Coordinate and maintain routine Quality Management System (QMS) activities within the electronic quality system (e-QMS), including quality records, CAPAs, nonconformances, supplier records, and training documentation. Support document control processes, including creation, review, routing, filing, and maintenance of SOPs, work instructions, forms, and quality records. Coordinate complaint handling activities, including intake, documentation, follow-up, and escalation of potential quality or regulatory concerns. Collaborate with internal teams, suppliers, manufacturers, and external partners to ensure complete and accurate quality and complaint records. Support CAPA, nonconformance, supplier management, and audit activities by maintaining records, tracking actions, and assisting with investigations and follow-up. Collect, organize, and report quality data and metrics to support management reviews and continuous improvement activities. Assist with inspections, product release documentation, validation, risk management, and maintenance of quality and technical documentation. Participate in training activities and ensure compliance with applicable procedures, quality standards, and regulatory requirements. Support additional Quality and Regulatory Affairs activities as required. Qualifications Associate degree or bachelor's degree in science, engineering, healthcare, quality, or a related field, or equivalent experience in a regulated industry. 2–5 years of experience working within Quality Assurance, Regulatory Affairs, or a related regulated environment. Working knowledge of Quality Management Systems (QMS). Practical understanding of medical device quality processes, including document control, CAPA, nonconformance management, complaint handling, training records, and supplier management. Strong attention to detail and a structured approach to managing quality records and deadlines. Strong written and verbal communication skills. Proficiency with Microsoft 365 and electronic quality management systems. Ability to work independently while collaborating effectively with cross-functional teams. Professional, reliable, and committed to maintaining high quality standards. What We Offer At Mermaid Medical, you will join a collaborative and international organization where quality, teamwork, and patient impact are at the center of everything we do. Our benefits package for full-time employees includes: 10 paid holidays annually Paid time off 100% employer-paid employee health and dental insurance premiums Option to add family coverage Retirement plan with company match Tuition assistance and educational support Why Mermaid Medical? We are a company built on collaboration, openness, and mutual support. Across functions, countries, and departments, we work together to make a meaningful difference for healthcare professionals and the patients who depend on our products. Our culture is guided by our belief that We Are One . We value teamwork, trust, and a shared commitment to quality. We are proud of the life‑changing medical devices we develop and distribute, and we believe our success comes from supporting one another while always putting patients first. About Mermaid Medical Group Mermaid Medical Group is a privately owned company founded in 2007. Headquartered in Denmark, we develop, manufacture, and distribute medical devices to hospitals and healthcare professionals across Europe, the United States, and Asia. Our primary focus is on products used in vascular treatment and interventional radiology. We strive to be the preferred partner for both manufacturers and healthcare providers, helping improve patient outcomes through innovative medical solutions. Job Type: Full-time Location: Sarasota, FL (On-site) Health insurance Paid time off Retirement plan with company match Schedule Monday to Friday on site Preferred Experience 2–5 years of Quality Assurance, Regulatory Affairs, or related experience in a regulated industry. #J-18808-Ljbffr

Vacancy posted 5 days ago
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