Quality Engineer II

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

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.