Senior Quality Engineer - Medical Devices & Validation

Katalyst CRO; Louisville (KY); On-site; USD 85,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a Quality Engineer with 5+ years in the medical device sector. You will drive quality processes, validation, and manufacturing support for surgical products and implants, ensuring compliance with GMP, ISO 13485, and FDA requirements.

Responsibilities include process validation, risk assessments, and data-driven decision making, with cross-functional collaboration across engineering and operations teams.

Qualifications

• Experience in GMP and ISO regulated medical industry.
• Ability to analyze and present data to drive decisions.
• Hands-on troubleshooting in FDA-regulated environments recommended.

Responsibilities

• Conduct process validation (IQ/OQ/PQ) and PFMEA/DFMEA activities.
• Interpret CMM and dimensional inspection reports and GD&T.
• Lead risk assessments and control plans for medical devices.
• Support supplier qualification and new product commercialization.

Skills

GMP experience

ISO standards

Data analysis

Six Sigma

GD&T interpretation

Root cause analysis

Education

Bachelor in Mechanical Engineering

Tools

Minitab

Excel

Job description

Katalyst CRO is seeking a Quality Engineer with 5+ years in the medical device sector. You will drive quality processes, validation, and manufacturing support for surgical products and implants, ensuring compliance with GMP, ISO 13485, and FDA requirements.

Responsibilities include process validation, risk assessments, and data-driven decision making, with cross-functional collaboration across engineering and operations teams.