Quality Engineer II: Medical Devices Quality & CAPA

Glaukos Corporation; San Clemente (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Glaukos Corporation in San Clemente, CA is seeking a Quality Engineer II to support the development and manufacturing of Class III medical devices. You will collaborate with Medical Safety, Product Development and Manufacturing to resolve quality issues and drive process improvements.

Responsibilities include leading CAPA investigations, reviewing changes, performing trend analysis, ensuring compliance with GMP and ISO 13485, and mentoring junior staff.

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 including test protocols and statistical techniques.
• Working understanding of GMP and ISO 13845 requirements.

Responsibilities

• Support development and manufacturing of Class III medical devices.
• Resolve product quality issues with Medical Safety, Product Development and Manufacturing.
• Initiate and investigate CAPA as appropriate.
• Lead and perform complaint evaluation as appropriate.
• Train, coach, and guide lower-level employees on routine procedures.
• Develop trend requirements for QA/QC in NCR, CAPA, and SPC processes.

Education

Bachelor's degree in Engineering or Science

Job description

Glaukos Corporation in San Clemente, CA is seeking a Quality Engineer II to support the development and manufacturing of Class III medical devices. You will collaborate with Medical Safety, Product Development and Manufacturing to resolve quality issues and drive process improvements.

Responsibilities include leading CAPA investigations, reviewing changes, performing trend analysis, ensuring compliance with GMP and ISO 13485, and mentoring junior staff.