Sr. Sustaining Quality Engineer

Company Description Apyx Medical is an advanced energy technology company dedicated to improving lives through innovative products in the cosmetic and surgical markets. Known for Renuvion® and J-Plasma® helium plasma technologies, the organization focuses on delivering transformative solutions to healthcare professionals and patients. Formerly Bovie® Medical, Apyx Medical leverages decades of experience and expertise in specialized energy waveforms. The company is committed to meeting evolving clinical needs and market opportunities through continuous innovation and high standards of product performance.

Role Description The Sr. Sustaining Quality Engineer is a full-time, on-site role based in Largo, FL, responsible for supporting and improving the quality of existing products throughout their lifecycle. This role includes investigating product quality issues, leading root cause analysis, and implementing corrective and preventive actions in collaboration with cross-functional teams such as R&D, manufacturing, and regulatory affairs. The Sr. Sustaining Quality Engineer will maintain and enhance quality systems and documentation, monitor product performance data, and support risk management and design changes to ensure ongoing compliance with applicable standards and regulations. Day-to-day activities also involve participating in audits, driving continuous improvement initiatives, and providing technical guidance to support safe, reliable, and effective medical devices.

Qualifications

• Strong foundation in Quality Engineering and Quality Assurance to support product lifecycle activities and compliance with medical device regulations.
• Experience in Quality Control and Product Quality to monitor, analyze, and improve product performance using data-driven methods.
• Background in Quality Management, including maintaining quality systems, documentation, and process controls in a regulated environment.
• Bachelor’s degree in engineering or a related technical field; advanced degree or relevant certifications (e.g., ASQ CQE) are beneficial.
• Knowledge of medical device standards and regulations (e.g., ISO 13485, FDA QSR) and experience with risk management tools such as FMEA.
• Proficiency in root cause analysis, statistical techniques, and problem-solving methodologies to drive corrective and preventive actions.
• Effective communication, collaboration, and documentation skills, with the ability to work cross-functionally and lead quality initiatives.
• Experience in sustaining engineering or post-market product support within the medical device or healthcare technology industry is preferred.