Senior Quality Engineer - Medical Devices (Hybrid Remote)

Glaukos Corporation; Burlington (MA); Hybride; USD 110 000 - 140 000; Plein temps

Résumé du poste

Glaukos Corporation in Massachusetts seeks a Quality/Manufacturing Engineer to lead design, development, and Validation of class III medical device processes. You will work with Quality Engineering, Product Development, and Manufacturing to scale up production, transfer designs, and ensure GMP/PPAP compliance.

The role emphasizes risk analyses, CAPA, NCR handling, data-driven process improvements, and supplier coordination.

Qualifications

• Master's degree in Industrial/Manufacturing Engineering or related field.
• 2 years of experience in Industrial/Manufacturing/Quality/Supplier Development Engineer or related occupation.
• Experience with Manufacturing process validation and GMP.
• Experience with statistical tools (Std dev, control charts, Pareto, histograms, trend analysis, Six Sigma).
• Structured manufacturing frameworks (APQP & PPAP).
• DFM, risk analysis, FMEA, testing requirements and methods.
• NCR, CAPA, and SPC processes.
• Evaluating supplier technical capabilities.
• Coordinating activities with internal departments and outside vendors/suppliers.

Responsabilités

• Lead design, development and review of manufacturing process changes and product design improvements.
• Lead transfer of new designs from development to production by assessing supplier capabilities.
• Provide technical oversight for product/process validations and related requirements.
• Write, review and approve validation protocols, test procedures and reports.
• Develop and manage equipment and facility (incl. clean room) validation programs and risk analyses.

Connaissances

Statistical analysis

Quality engineering

Process validation

Formation

Master's degree in Industrial/Manufacturing Engineering

Outils

APQP

PPAP

FMEA

Description du poste

Glaukos Corporation in Massachusetts seeks a Quality/Manufacturing Engineer to lead design, development, and Validation of class III medical device processes. You will work with Quality Engineering, Product Development, and Manufacturing to scale up production, transfer designs, and ensure GMP/PPAP compliance.

The role emphasizes risk analyses, CAPA, NCR handling, data-driven process improvements, and supplier coordination.