Glaukos

Sr. Quality Engineer II / Sr. Quality Specialist II

Glaukos • $100K — $130K *
San Clemente, CA 92672In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Reposted Today
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Job Overview by Ladders

Qualifications

  • 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
  • ASQ certifications (CQE, CQA, CBA) a plus
  • Detail-oriented, highly organized, and a natural collaborator

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

Benefits

  • Opportunity to impact eye health and improve patient outcomes
  • Collaborative environment with cross-functional teams
  • Focus on innovative and game-changing technologies
  • Commitment to continuous improvement and professional growth
  • Family-oriented and socially responsible company culture
Full Job Description
Job Description

Sr. Quality Engineer II / Sr. Quality Specialist II

Join a team that's redefining the future of ophthalmic treatment. We're seeking a Sr. Quality Engineer II or Sr. Quality Specialist II to support the manufacturing and continuous improvement of our innovative combination products (pharmaceutical and medical device). In this role, you'll ensure flawless product transfers into production, lead risk management initiatives, and champion quality across operations, development, and compliance.

What You'll Do:
  • Work with the Manufacturing and QC Analytical Departments as Quality Assurance (QA) representative providing QA oversight and support to ensure compliance to GMP.
  • Drive quality on the manufacturing floor - from nonconformance investigations to process optimization.
  • Identify compliance risks and to ensure quality and regulatory compliance with 21 CFR Parts 210/211, 820, ISO 13485, USP and ICH guidelines.
  • 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.
  • Author and perform quality review of deviations, out of specification result investigations, non-conformances, and CAPA, as needed ensuring that Quality System records are completed in accordance with guidelines and performed in a timely manner.

What You Bring:
  • Bachelor's degree in Engineering, Science, or related field.
  • 8+ years of relevant experience (5+ years in pharmaceutical required; 10+ preferred).
  • Experience with QC analytical method validation, raw material and final product testing, and stability programs in a regulated environment.
  • Strong knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, 21 CFR Parts 210/211, USP and ICH guidelines.
  • ASQ certifications (CQE, CQA, CBA) a plus.
  • Detail-oriented, highly organized, and a natural collaborator.

#GKOSUS

About Glaukos

Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company's second-generation MIGS device, the iStent inject, was approved by the FDA in June 2018. Glaukos is also developing a pipeline of innovative technologies in corneal health, including the recently acquired Microline surgical platform, as well as novel drug delivery technologies.
Learn more about Glaukos
Size
727 employees
Market Cap
$1.9 billion
Industry
Healthcare
Net Income
-$120.3 million
Founded
1998
5 Year Trend
+20.8%
Revenue
$224.9 million
NASDAQ
GKOS
* Ladders Estimates

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