Quality Systems Manager

Quality Management System Leader

Lead and continuously improve the Quality Management System (QMS) to ensure compliance with regulatory requirements, quality standards, and company objectives while fostering a culture of quality and operational excellence.

Lead the implementation, maintenance, and continuous improvement of the QMS across the organization.

Oversee key quality system functions, including document control, CAPA, internal audits, training, and management reviews.

Drive quality and compliance initiatives by partnering with cross-functional teams to improve processes and regulatory readiness.

Manage external audits and inspections, including preparation, execution, responses, and follow-up activities.

Partner with cross-functional departments to drive quality system effectiveness and ensure consistent execution of quality processes and procedures.

Develop, coach, and support quality team members while monitoring quality system performance metrics and continuous improvement efforts.

Required Qualifications:

• Bachelor's degree and 8+ years of experience in Quality Assurance, Quality Systems, or related medical device quality functions.
• Minimum 1 year of people leadership, supervisory, or management experience.
• Strong knowledge of FDA Quality System Regulation (QSR), ISO 13485, and applicable medical device quality requirements.
• Experience managing audits, CAPA programs, document control, and Quality Management System activities in a regulated environment.
• Experience leading cross-functional projects and driving quality system improvements.
• Ability to analyze quality metrics and translate findings into actionable improvements.
• Strong written, verbal, organizational, and leadership skills.
• Quality certifications (ASQ CQE, CQA, or equivalent) preferred.
• This role is based onsite in Aliso Viejo, CA or Burlington, MA.

About Us

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.

All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.

Job Info

• Job Identification 2404
• Job Category Quality
• Job Schedule Full time
• Locations Aliso Viejo, CA or Burlington, MA
• Job Salary Range 107,700.00 - 134,600.00