Senior Quality Engineer - Medical Devices (Hybrid Remote)

Glaukos Corporation; Burlington (AL); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Glaukos Corporation, a leader in ophthalmic medical devices, seeks a Quality/Manufacturing Process Engineer to drive the design, development and scale-up of new products and process changes. You will lead validations, control plans, and supplier evaluations to ensure quality and regulatory compliance across development and production teams.

The role requires expertise in GMP, APQP/PPAP, risk analysis, and data-driven quality improvement, with collaboration across Product Development, Applied

Qualifications

• Master's degree in Industrial/Manufacturing Engineering or related field.
• 2 years of relevant experience in industrial/manufacturing/quality/supplier development engineering or related occupation.
• Proficiency with manufacturing validation and GMP practices.
• Experience with APQP/PPAP and quality system tools.

Responsibilities

• Lead design, development, and review of manufacturing process changes and product design improvements to scale up new products.
• Provide technical oversight for validation protocols, test procedures, and reports; ensure compliance with risk analyses and design controls.
• Coordinate with Product Development, Applied Research, Manufacturing and vendors to transfer designs from development to production.
• Develop and manage equipment/ facility requirements, including clean room validation and qualification programs.
• Initiate and drive CAPA investigations and support complaint analysis and data trend review.

Skills

Manufacturing validation

GMP experience

APQP

PPAP

DFM

Risk analysis

FMEA

NCR/CAPA/SPC

Supplier evaluation

Excellent communication

Education

Master's degree in Industrial/Manufacturing Engineering

Job description

Glaukos Corporation, a leader in ophthalmic medical devices, seeks a Quality/Manufacturing Process Engineer to drive the design, development and scale-up of new products and process changes. You will lead validations, control plans, and supplier evaluations to ensure quality and regulatory compliance across development and production teams.

The role requires expertise in GMP, APQP/PPAP, risk analysis, and data-driven quality improvement, with collaboration across Product Development, Applied