Sr. Quality Engineer II jobs in United States
cer-icon
Apply on Employer Site
company-logo

Glaukos Corporation · 4 months ago

Sr. Quality Engineer II

positionSan Clemente, CA, United States
timeFull-time
remoteOnsite
senioritySenior Level, Lead/Staff
money$109K/yr - $142K/yr
date8+ years exp

Glaukos Corporation is seeking a Sr. Quality Engineer II to support the manufacturing and continuous improvement of innovative medical devices in ophthalmology. The role involves ensuring flawless product transfers into production, leading risk management initiatives, and championing quality across operations, development, and compliance.

Health CareMedicalWellness
check
Growth Opportunities
check
H1B Sponsor Likelynote

Responsibilities

Drive quality on the manufacturing floor – from nonconformance investigations to process optimization
Lead risk management activities and maintain compliance with ISO 14971
Ensure sterility assurance with gamma sterilization oversight, dose audits, and environmental monitoring
Support product validation (IQ/OQ/PQ), CAPAs, and quality system improvements
Collaborate with R&D, Operations, Clinical, and Regulatory teams to bring new products to market and elevate existing ones
Act as a quality leader, guiding audits and embedding a culture of compliance and excellence

Qualification

ISO 13485ISO 1497121 CFR Part 820Gamma sterilizationASQ certificationsHighly organizedNatural collaboratorDetail-oriented

Required

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
Detail-oriented, highly organized, and a natural collaborator

Preferred

10+ years of relevant experience
Gamma sterilization experience
ASQ certifications (CQE, CQA, CBA)

Company

Glaukos Corporation

twittertwittertwitter
company-logo
At Glaukos, our focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases—therapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.
dateFounded in 1998
location
San Clemente, California, USA
people-size1001-5000 employees
web-link
http://www.glaukos.com

H1B Sponsorship

Glaukos Corporation has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (6)
2023 (1)
2022 (3)
2021 (1)

Funding

Current Stage
Public Company
Total Funding
$121M
Key Investors
Meritech Capital PartnersOrbiMed
2015-06-25IPO
2013-02-07Series F· $30M
2012-10-03Debt Financing· $6M

Leadership Team

leader-logo
Alex Thurman
Senior Vice President and Chief Financial Officer
linkedin
leader-logo
Joseph Gilliam
President & Chief Operating Officer
linkedin

Recent News

BioSpace
Glaukos Announces Participation in J.P. Morgan Healthcare Conference
2025-12-17
MarketScreener
Transcript : Glaukos Corporation Presents at UBS Global Healthcare Conference 2025, Nov-11-2025 10
2025-11-11
Orange County Business Journal
Midday Stock Roundup: OC Firms Down on Quarterly Results
2025-11-09
Company data provided by crunchbase