Glaukos

Medical devices for glaucoma treatment

Quality Engineer 2

Quality EngineeringConfirmed live in the last 24 hours

Full-timeSan Clemente, CA, USA$73.6k - $92k /yrIn-person

About the Job

Requirements

A bachelor's degree in Engineering or Science is required.
Two to five years of relevant work experience is required.
Strong knowledge of medical device manufacturing is required.
Expertise in medical product quality assurance, including test protocol requirements and statistical techniques, is required.
A working understanding of Good Manufacturing Practices and ISO 13845 requirements is required.
Hands-on involvement with all phases of projects is required.
Excellent documentation skills with attention to detail and accuracy are required.
The candidate must be an effective written and oral communicator and work collaboratively.

Responsibilities

Support the development and manufacturing of Class III medical devices.
Work with Medical Safety, Product Development, and Manufacturing to resolve product quality issues.
Support manufacturing process changes, product design improvements, and implementation of new products.
Support Quality Engineering and other functional groups in product nonconformity investigations.
Review process changes and resolve product quality issues.
Initiate and investigate Corrective and Preventive Actions as appropriate.
Lead and perform complaint evaluations as appropriate.
Train, coach, and guide lower-level employees on routine procedures.
Develop trend requirements for nonconformance reports, Corrective and Preventive Actions, and statistical process control processes covering incoming inspection, process, and vendor operations.
Evaluate data, identify trends, and develop innovative solutions.
Develop and establish effective quality control.
Write, review, and approve process and product validation protocols and reports, equipment qualifications, and document change orders.
Use statistical tools to analyze data, make acceptance decisions, and improve processes.
Provide technical assistance and oversight in defining and conducting internal and external product and process validations and requirements.
Work with Product Development, Applied Research, Manufacturing personnel, and vendors on validation activities.
Write, perform, and review validation protocols, test procedures, and test reports.
Conduct, document, and maintain risk analyses for development products and comply with risk analysis, design control, and related procedures.
Manage equipment and facility requirements, design, maintenance, calibration, and validation programs, including clean-room requirements.
Ensure compliance with federal, state, local, and company regulations, policies, and procedures.
Perform other quality-related duties assigned by management.
Assist with creating quality-improvement efforts for legacy products, continuous improvement, and customer satisfaction.

Desired Qualifications

Experience working in a clean room and/or performing in-process assembly and manufacturing verification inspections.

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

Job Salary Range: 73,600.00 - 92,000.00

About the Company

Glaukos

Medical devices for glaucoma treatment

Glaukos focuses on ophthalmology by developing and commercializing medical devices and therapies for glaucoma, corneal disorders, and retinal diseases. Its products mainly target surgeons who treat eye conditions, with a core technology in micro invasive glaucoma surgery (MIGS). The company’s MIGS devices, such as the Trabecular Micro Bypass Stent and next-generation iStent, are implanted in the eye to improve outflow of eye fluid and lower intraocular pressure, offering a less invasive option compared with traditional surgeries. Glaukos differentiates itself by pioneering MIGS and bringing the first US-approved MIGS device to market in 2012, continuing to expand its portfolio through research, development, and strategic acquisitions. The company aims to improve patient care by providing safer, effective, and longer-lasting treatment options for glaucoma and related eye diseases, addressing unmet needs in ophthalmology.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Aliso Viejo, CA
Founded: 1998

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