Senior Quality Engineer, Medical Devices & Validation

Katalyst CRO; Cincinnati (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO in Cincinnati, OH is seeking a Quality Engineer with 5+ years in the medical device industry to lead quality, validation, and manufacturing engineering for surgical products and implants.

You will drive IQ/OQ/PQ, PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification in GMP/ISO/FDA environments, collaborating across functions to ensure robust processes and successful product launches.

Qualifications

• Bachelor's in mechanical engineering or equivalent; min. 5 years in Quality/Validation/Manufacturing in medical devices.
• Experience in GMP and ISO 13485 and FDA compliance preferred.
• Knowledge of process validation (IQ/OQ/PQ) and risk assessment methodologies.

Responsibilities

• Support GMP/ISO regulated medical device environment and drive data-driven decisions.
• Perform and support process validation, PFMEA/DFMEA, and Gage R&R.
• Analyze dimensional data and root cause investigations; implement corrective actions.
• Support supplier qualification and new product validation from design to commercialization.
• Communicate findings and recommendations across multidisciplinary teams.

Skills

Data analysis

Gage R&R

SPC

DOE

MSA

PFMEA/DFMEA

Root cause analysis

GD&T

Cross-functional collaboration

Regulatory awareness

Education

Bachelor's in mechanical engineering

Tools

Minitab

Excel

Job description

Katalyst CRO in Cincinnati, OH is seeking a Quality Engineer with 5+ years in the medical device industry to lead quality, validation, and manufacturing engineering for surgical products and implants.

You will drive IQ/OQ/PQ, PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification in GMP/ISO/FDA environments, collaborating across functions to ensure robust processes and successful product launches.