Senior Quality Engineer, Medical Devices & Validation

Katalyst CRO; San Antonio (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

Katalyst CRO seeks a Quality Engineer with 5+ years in medical device quality, validation, and manufacturing engineering for surgical products and implants.

You will lead process validation, PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification within GMP/ISO/FDA environments, driving continuous improvement.

Strong data analysis, GD&T interpretation, and cross-functional collaboration are essential for quality and regulatory compliance.

Qualifications

• GMP/ISO medical industry experience required.
• Experience with data analysis to support decision making.
• Hands-on troubleshooting in FDA-regulated environments.

Responsibilities

• Experience in GMP/ISO regulated medical industry is required.
• Ability to analyze and present data that facilitates and drives decision making.
• Hands-on troubleshooting and problem solving; FDA-regulated environment preferred.

Skills

Quality engineering

Data analysis

Root cause investigation

Cross-functional collaboration

Statistical methods

GD&T interpretation

Education

Bachelor in Mechanical Engineering

Tools

Minitab

Excel

CMM reports

Job description

Katalyst CRO seeks a Quality Engineer with 5+ years in medical device quality, validation, and manufacturing engineering for surgical products and implants.

You will lead process validation, PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification within GMP/ISO/FDA environments, driving continuous improvement.

Strong data analysis, GD&T interpretation, and cross-functional collaboration are essential for quality and regulatory compliance.