Quality Engineer

Quality Engineer – Medical Device Industry Location/Onsite: Boca Raton, FL – Full-Time, Onsite Our client, a fast-growing medical device company focused on revolutionizing radiation oncology, is looking for a skilled Quality Engineer to join their team in Boca Raton, FL. Are you passionate about quality management systems, ISO 13485 , and regulatory compliance in the medical device industry? Do you have experience supporting product development and lifecycle management? If so, this could be the perfect role for you. Keep scrolling to learn more about this exciting opportunity The Perks Competitive salary based on experience ($80,000-90,000k/year) Health, dental, and vision insurance options Generous paid time off (PTO) and paid holidays 401(k) retirement plan with company match A Day in the Life of a Quality Engineer In this hands-on role, you’ll be responsible for ensuring the quality of medical device products from design to manufacturing. As a key member of the quality team, you'll collaborate across departments to implement and improve the Quality Management System (QMS), ensuring compliance with FDA and ISO 13485 standards. Your work will be crucial to ensuring that products meet the highest standards of quality and regulatory compliance throughout their lifecycle. Responsibilities include: Develop, implement, and refine the Quality Management System processes as the company scales and product lines expand. Ensure compliance with ISO 13485 and FDA regulatory requirements for all products and services. Review and approve quality plans, protocols, procedures, and reports to maintain consistency, traceability, and strong documentation practices. Collaborate with all departments to ensure process interactions are compliant with the QMS. Provide quality engineering support for product lifecycle management, from design through manufacturing. Assist with risk management, corrective and preventive actions (CAPA), document controls, and customer complaints. Support outsourced services and suppliers with quality engineering guidance. Establish inspection, testing, and measurement methods and procedures. Perform internal audits to ensure compliance with established quality standards. Requirements and Qualifications: 1-3 years of experience in the design or manufacturing of FDA Class II medical devices. Minimum 2-year college degree required; Bachelor’s degree in a related STEM field . Experience with Quality Management Systems (ISO 13485/ISO 9001), internal auditing, and supplier quality. Familiarity with software and hardware integrated medical products. Experience with sterile medical devices is a plus. Strong attention to detail and analytical skills, with the ability to review documentation and make decisions based on compliance standards. Proficiency with Microsoft Office and eQMS/ERP systems. Excellent written and verbal communication skills, with the ability to work cross-functionally across the organization. Self-motivated, team-oriented individual who can handle multiple tasks with minimal supervision. About the Hiring Company: Our client is a cutting-edge company on a mission to transform radiation oncology. They are dedicated to developing innovative, high-quality medical devices that will make a significant impact in the healthcare field. As a growing organization, they are committed to fostering an inclusive and collaborative work environment while maintaining the highest standards of regulatory compliance and product quality. Come Join Our Quality Team Start by filling out this 3-minute, mobile-friendly application here. We look forward to hearing from you