Glaukos

Quality Engineer II

Glaukos • $80K — $95K *
San Clemente, CA 92672In-Person
Healthcare
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering or Science
  • 2-5 years of relevant work experience
  • Strong knowledge of medical device manufacturing
  • Expertise in medical product quality assurance
  • Working understanding of GMP and ISO 13845 requirements
  • Experience working in a clean room
  • Excellent documentation skills and attention to detail
  • Team player with strong communication skills

Responsibilities

  • Support development and manufacturing of Class III medical devices
  • Investigate product nonconformities with cross-functional teams
  • Initiate and manage Corrective and Preventative Actions (CAPA)
  • Lead complaint evaluations and provide necessary resolutions
  • Train and guide junior staff on Quality Assurance processes
  • Develop trend requirements for QA/QC metrics
  • Conduct risk analyses for development products

Benefits

  • Opportunities for professional development
  • Collaborative work environment
  • Contribute to innovative healthcare solutions
  • Engagement in cross-functional projects
  • Employee support for continuous improvement initiatives
Full Job Description
Job Description

GLAUKOS - QUALITY ENGINEER II (San Clemente, CA)

What You'll Do:

The Quality Engineer II will support the development and manufacturing of Class III medical devices. This individual will work with Medical Safety, Product Development and Manufacturing to resolve product quality issues. The Quality Engineer II will also support manufacturing process changes, product design improvements and the implementation of new products.
  • Primary responsibilities include working in Quality Engineering and with other functional groups in support of product nonconformity investigation.
  • Review process changes and resolve product quality issues.
  • Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
  • Lead and perform complaint evaluation as appropriate.
  • Train, coach, and guide lower-level employees on routine procedures.
  • Develop trend requirements to support the QA/QC department in the following areas: NCR, CAPA, and SPC processes for incoming inspection, process, and vendor operations. Evaluates data and identifies trends in order to develop innovative solutions.
  • Develop and establish effective quality control
  • Write, review and/or approve process and product validation protocols and reports, equipment qualifications, document change orders.
  • Use statistical tools to analyze data, make acceptance decisions, and improve process
  • Provides technical assistance/oversight in defining and conducting both internal and external product and process validations and requirements, working closely with Product Development, Applied Research, and Manufacturing personnel as well as vendors. Writes, performs, and/or reviews technical documents such as Validation Protocols, Test Procedures, and Test Reports.
  • Responsible for conducting, documenting, and maintaining risk analyses for all development products and complying with risk analysis, design control, and any other related procedures.
  • Manage equipment and facility (including clean room) requirements, design, maintenance, calibration and validation programs.
  • Ensure compliance with all Federal, State, local and company regulations, policies, and procedures.
  • Performs other quality-related duties as assigned by management.
  • Assists with creation of new efforts with quality improvement opportunities as appropriate to legacy products, continuous improvement, and customer satisfaction.

How You'll Get There:
  • Bachelor's degree in Engineering or Science
  • 2-5 years of relevant work experience
  • Strong knowledge of medical device manufacturing
  • Expertise in medical product quality assurance (including the requirements for test protocols and statistical techniques)
  • Working understanding of GMP and ISO 13845 requirements
  • A work style of hands-on involvement with all phases of projects
  • Experience working in a clean room and/or performing in-process assembly and manufacturing verification inspections desirable
  • Excellent documentation skills with attention to detail and accuracy Required
  • Team player, good written/oral communicator

#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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