Sr. Quality Engineer II
Glaukos CorporationSan Clemente, California, United States
Posted September 12, 2025
Full Time
About the Company
Glaukos Corporation is dedicated to advancing ophthalmic care through the development of innovative therapies for glaucoma, corneal disorders, and retinal diseases. The company specializes in minimally invasive glaucoma surgery (MIGS) devices and pharmaceuticals, aiming to improve patient outcomes and treatment options globally.
Job Description
Glaukos Corporation is seeking a Sr. Quality Engineer II to support the manufacturing and continuous improvement of their medical devices, specifically for Ophthalmology. This role involves driving quality on the manufacturing floor, leading risk management initiatives, and championing quality across operations and compliance. The ideal candidate will have a strong understanding of FDA regulations and ISO standards.
Requirements
- 8+ years of relevant experience (5+ years in medical devices required; 10+ preferred)
- Strong knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971.
- Background in sterilization methods (gamma preferred) and lab testing.
- Bachelor’s degree in Engineering, Science, or related field.