Senior Quality Engineer - Medical Devices & Validation

Creative Solutions Services, LLC; Louisville (KY); On-site; USD 85,000 - 110,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Quality Engineer with 5+ years in the medical device industry to drive quality, validation, and manufacturing engineering for surgical products and implants in Louisville.

You’ll lead IQ/OQ/PQ, PFMEA/DFMEA, Gage R&R, SPC/DOE, and supplier qualification, analyze data for decisions, review CMM reports, and ensure GMP, ISO 13485 and FDA compliance.

Strong problem-solving, cross-functional collaboration, and a focus on continuous improvement are essential.

Qualifications

• Experience in GMP/ISO medical industry.
• Proficient in data analysis to support decision making.
• Hands-on troubleshooting in FDA-regulated environments preferred.
• Advanced statistics and Lean Six Sigma methods preferred.
• Reading CMM and dimensional inspection reports.
• New product launch validation and commercialization experience.
• PFMEA/DFMEA, Gage R&R, TMV, Risk Assessments, and Control Plans.

Responsibilities

• Analyze data to support decisions in manufacturing quality.
• Lead process validation and qualification activities (IQ/OQ/PQ).
• Develop PFMEA/DFMEA, Gage R&R, and control plans.
• Review CMM and dimensional data reports.
• Support new product launches through full validation.
• Collaborate across multidisciplinary teams.
• Ensure documentation meets regulatory requirements.
• Apply Six Sigma tools to drive improvements.

Skills

Quality Engineering

Statistical Analysis

Six Sigma

Process Validation

Gage R&R

DOE

SPC

Root Cause Analysis

GD&T

Education

Bachelor in Mechanical Engineering

Tools

Minitab

Excel

Job description

Creative Solutions Services, LLC seeks a Quality Engineer with 5+ years in the medical device industry to drive quality, validation, and manufacturing engineering for surgical products and implants in Louisville.

You’ll lead IQ/OQ/PQ, PFMEA/DFMEA, Gage R&R, SPC/DOE, and supplier qualification, analyze data for decisions, review CMM reports, and ensure GMP, ISO 13485 and FDA compliance.

Strong problem-solving, cross-functional collaboration, and a focus on continuous improvement are essential.