Senior Quality Engineer, Medical Devices & Validation

Creative Solutions Services, LLC; Cincinnati (OH); On-site; USD 85,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC in Cincinnati, Ohio, is seeking a Quality Engineer with 5+ years in medical devices to drive quality, validation, and manufacturing engineering for surgical products and implants.

The role emphasizes IQ/OQ/PQ validation, PFMEA/DFMEA, MSA, SPC, DOE, GD&T, and supplier qualification within GMP, ISO 13485 and FDA environments, with a strong focus on data-driven decision making and cross-functional collaboration.

Qualifications

• Bachelor's in mechanical engineering or equivalent; 5+ years in Quality/Validation/Manufacturing in medical devices

Responsibilities

• Analyze data to drive decisions in GMP/ISO-regulated medical environments.
• Hands-on troubleshooting and problem solving in a production setting.
• Lead PFMEA/DFMEA, Gage R&R, TMV, Risk Assessments and Control Plans.
• Support new product launches through full validation and commercial launch.
• Read and interpret CMM reports and dimensional inspection data.
• Ensure documentation meets regulatory requirements and traceability.

Skills

Process Validation

Gage R&R

PFMEA/DFMEA

Statistical Analysis

DOE

Six Sigma

Root Cause Analysis

GD&T

Documentation & Compliance

Cross-functional Collaboration

Education

Bachelor's in Mechanical Engineering

Equivalent Experience

Tools

Minitab

Excel

Job description

Creative Solutions Services, LLC in Cincinnati, Ohio, is seeking a Quality Engineer with 5+ years in medical devices to drive quality, validation, and manufacturing engineering for surgical products and implants.

The role emphasizes IQ/OQ/PQ validation, PFMEA/DFMEA, MSA, SPC, DOE, GD&T, and supplier qualification within GMP, ISO 13485 and FDA environments, with a strong focus on data-driven decision making and cross-functional collaboration.