Senior Quality Engineer, Medical Devices & Validation

Katalyst CRO; Olympia (WA); On-site; USD 105,000 - 145,000; Full time

Job summary

Katalyst CRO is seeking a Quality Engineer with 5+ years in the medical device sector, focusing on quality, validation, and manufacturing engineering for surgical products and implants. The role emphasizes process validation (IQ/OQ/PQ), PFMEA/DFMEA, Gage R&R, SPC, DOE, and supplier qualification in GMP/ISO/FDA environments.

The candidate will read GD&T, analyze dimensional data, conduct root-cause investigations, and drive continuous improvement initiatives across cross-functional teams.

Qualifications

• Requires GMP/ISO FDA-regulated environment experience.
• Ability to analyze and present data to drive decisions.
• Hands-on troubleshooting in a FDA-regulated setting preferred.

Responsibilities

• Experience in GMP/ISO regulated medical industry required.
• Analyze and present data to facilitate decision making.
• Hands-on troubleshooting in production environment preferred; advanced statistics and Six Sigma methods preferred.
• Process validation and supplier qualification experience preferred.
• Interpret CMM and dimensional inspection reports.
• Read and interpret GD&T and dimensional data.
• New product launch through full validation and commercial launch.

Skills

Data analysis

Cross-functional collaboration

Problem solving

Quality engineering

Strong communication

GD&T interpretation

Education

Bachelor in Mechanical Engineering

Tools

Minitab

Excel

CMM interpretation

Job description

Katalyst CRO is seeking a Quality Engineer with 5+ years in the medical device sector, focusing on quality, validation, and manufacturing engineering for surgical products and implants. The role emphasizes process validation (IQ/OQ/PQ), PFMEA/DFMEA, Gage R&R, SPC, DOE, and supplier qualification in GMP/ISO/FDA environments.

The candidate will read GD&T, analyze dimensional data, conduct root-cause investigations, and drive continuous improvement initiatives across cross-functional teams.