Location: Rancho Santa Margarita, CA
Cap-Exempt H-1B Position — No lottery required
Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions. **Position Description** The Quality Engineer I/II supports Applied Medical’s Quality System by enhancing manufacturing and quality processes across a broad range of medical device technologies. This position plays a key role in ensuring the safety, performance, and reliability of products such as the Kii® access device and other minimally invasive surgical solutions. The Quality Engineer partners with cross‑functional engineering teams to strengthen product quality, maintain regulatory compliance, and drive continuous improvement within medical device development. This role is well suited for individuals interested in quality engineering, medical device engineering, product development engineering, and manufacturing quality assurance. **Key Responsibilities:** - Maintain and improve elements of the Quality Management System by identifying opportunities to enhance process efficiency and compliance. - Monitor quality metrics and trends and lead the preparation and presentation of insights and recommendations during management reviews. - Develop and revise process control documentation, including work instructions, control plans, test methods, and graphical aids. - Perform statistical analysis to support product verification, process control, and continuous improvement initiatives. - Troubleshoot equipment, process, and product issues and collaborate with engineering teams to implement effective corrective actions. - Participate in and assess in