Hybrid Principal Quality Engineer at Glaukos Corporation
Glaukos Corporation · Aliso Viejo, United States Of America · Hybrid
- Senior
- Office in Aliso Viejo
Principal Quality Engineer
How You’ll Make an Impact
As a Principal Quality Engineer, you will play a critical role in ensuring the successful transfer of products into manufacturing, driving risk management activities, and maintaining regulatory compliance. Your expertise will support both the development of new products and the optimization of existing ones, ensuring product safety, quality, and performance. By leading validations, overseeing sterilization and environmental monitoring programs, and partnering with cross-functional teams, you will help deliver life-changing medical therapies to patients.
What Will You Do?
- Product Transfer & Operations
- Lead validations (IQ/OQ/PQ) and ensure new product processes meet high-quality standards.
- Monitor inspection results and trends to ensure products meet specifications and performance criteria.
- Oversee sterility assurance, including gamma sterilization processes, dose audits, and environmental monitoring.
- Provide “quality on the floor” support, including analytical testing, gage R&R studies, and process optimization.
- Risk Management & Quality Systems
- Maintain ISO 14971-compliant risk management files for all product lines.
- Lead risk management activities and integrate risk analysis across the quality management system.
- Support CAPA investigations, lead quality system improvements, and ensure documentation meets regulatory standards.
- Participate in internal and supplier audits, close findings, and drive corrective/preventive actions.
- Apply systematic problem-solving to identify, prioritize, and resolve quality issues.
- Cross-Functional Leadership
- Partner with R&D, Operations, and Manufacturing teams to enhance processes and optimize product quality.
- Mentor team members on quality processes and technical problem-solving.
- Support initiatives that facilitate the achievement of operational, regulatory, and clinical objectives.
How Will You Get Here?
- Bachelor’s Degree in Engineering, Science, or related field.
- 12+ years of production or engineering experience, with 5+ years in medical device/pharma/combo product quality (10+ preferred).
- 3+ years of leadership experience (5+ preferred).
- Strong understanding of 21 CFR Part 820, ISO 13485, and ISO 14971 requirements.
- Experience with sterilization methods (gamma preferred), laboratory testing, and process validations.
- ASQ certifications (CQA, CBA, CQE) preferred.
Company
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.
Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.
Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra “We’ll Go First,” which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.
Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol “GKOS”. Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
