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# Quality Engineer II, Design

- **Company:** Glaukos Corporation
- **Location:** San Clemente, CA, United States
- **Experience:** Experienced
- **Contract:** Permanent contract
- **Skills:** Business Systems, Data Control, Verification and Validation (Software), Test Data
- **Published:** September 1, 2026
- **Apply:** https://jobs.localjobnetwork.com/apply/add/40753454/1

## About the Role

* 4 to 7 years work experience in a production or engineering environment and 3+ years as an engineering technician work.

 * 3+ years of medical device experience required.

 * Working understanding of 21 CFR Part 820 and ISO 13845 and 14971 requirements

 * Excellent documentation skills with attention to detail and accuracy

 * Must be self-motivated, goal-driven and results-oriented team player

 * Must be organized and able to coordinate activities with internal departments

Education:

Bachelor's Degree in Science or Engineering

## Description

The Quality Engineer II, Design, based in San Clemente, CA directly supports the full product lifecycle of innovative ocular medical device development; responsibilities include the execution of design control deliverables, risk management activities, Design History File compliance and leading assessment/implementation of design changes to already approved medical devices. This role will support the development of new product designs as well as the maintenance and enhancements of existing products.

Responsibilities & Work Experience:

Design Control:

Working with development teams to assure:

 * Clear and concise user requirements, product specifications, plans, verification and validation studies, risk management strategies and other relevant design control deliverables,

 * Test protocols that include qualified and repeatable test methods, appropriate risk-based sample sizes and clear test instructions that produce meaningful data,

 * Robust reports which include appropriately analyzed test data to support regulatory submissions and product launches,

 * Transfer plans that include complete DMR documents, quality control plans, training plans, approved suppliers and process validations,

 * Complete and accurate design history files.

Risk Management:

 * Maintain the risk management plans for all product lines ensuring compliance with ISO 14971.

 * Leads Risk Management activities for effective product development and operational activities.

 * Ensure feedback loops are implemented and effective.

 * Integrate risk management throughout the quality management system.

 * Provide risk analysis leadership for all departments.

Quality System:

 * Ensure all design control and risk management documents are maintained and meet regulatory requirements.

 * Participate in and lead investigations for CAPA, manufacturing or quality system projects.

 * Assess and improve quality system processes through data monitoring and trend analysis.

 * May participate in internal and supplier audits, conducting audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.

 * Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.

 * Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

 * Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.

 * Mentor for technical guidance for identifying and resolving quality issues.

Other Duties as Assigned:

 * Additional other duties and projects as required to facilitate R&D, Operations, Production, Engineering, Clinical and Regulatory goals and objectives.