The Principal Quality Engineer, Medical Device position will be based in San Clemente, CA and will directly support the manufacture of innovative ocular medical devices.

This role includes verifying successful transfer of products into manufacturing, the review and/or execution of validations (IQ/OQ/PQ), risk management activities, environmental monitoring, supporting quality control and manufacturing operations. Knowledge of gamma sterilization methods is preferred.

This role will support the development of new product designs as well as the maintenance and enhancements of existing products.

Operations

• Investigates and dispositions nonconformances identified during manufacturing and finished goods inspection.
• Monitor inspection results and trends to ensure products meet specifications and performance criteria.Work with product development teams to ensure new processes are capable to produce high quality medical devices.
• Ensures sterility assurance of Glaukos products with oversight of Gamma sterilization processes, quarterly dose audits and bioburden monitoring.
• Ensures proper execution of environmental monitoring program.

Risk Management

• Maintain the risk management files for all product lines in manufacturing and ensuring compliance with ISO 14971.
• Leads Risk Management activities for effective 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 operation, inspection 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
• Quality on the floor, supporting quality control analytical testing, gage R&R, process optimizations, etc.

Other Duties as Assigned

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

Work Experience:

• 12+ years of work experience in a production or engineering environment and 8+ years as an engineering technician work.
• 5+ years of medical device experience required, 10+ years preferred
• 3+ years of leadership required, 5+ years preferred.

Knowledge, Skills, and Abilities

• Working understanding of 21 CFR Part 820 and ISO 13845 and 14971 requirements
• Strong knowledge of medical device manufacturing.
• Knowledge in sterilization and laboratory testing.
• ASQ certifications preferred. CQA, CBA, CQE
• Excellent documentation skills, attention to detail and accuracy
• Team player, good written/oral communicator
• Must be organized and able to coordinate activities with internal departments and outside vendors

Education:

• Bachelor's Degree in Engineering, Science or related fields

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.