Quality Engineer

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

Job Description

Quality Engineer with 5+ years of experience in the medical device industry, specializing in quality, validation, and manufacturing engineering for surgical products and implants. Experienced in process validation (IQ/OQ/PQ), PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification within GMP, ISO, and FDA-regulated environments. Proficient in GD&T interpretation, dimensional data analysis, root cause investigation, and new product commercialization. Strong analytical, problem-solving, and cross-functional collaboration skills with a proven ability to drive quality, compliance, and continuous improvement initiatives.

Roles & Responsibilities

• Experience in a GMP and/or ISO regulated medical industry is required.
• Ability to analyze and present data that facilitates & drives decision making is required.
• The ability to perform "hands on " troubleshooting and problem solving is required Experience working in an FDA regulated environment is preferred.
• Experience working in operations supporting a production environment is preferred Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies (i.e. Measurement System Analysis, SPC, DOEs, Reliability, etc.) is preferred
• Technical understanding of manufacturing equipment and processes is preferred Process Validation expertise is preferred.
• Ability to read and interpret CMM and dimensional inspection reports.
• Experience with dimensional data analysis utilizing software (Excel or Minitab)
• Experience in Medical Standards and Quality process preferred.
• New product launch experience from through full validation and commercial launch
• Experience with PFMEA/DFMEA's, Gage R&R's, TMV's, Risk Assessments and Control Plan
• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
• Performance Component Qualification (Process Characterization, Process Capability Analysis, Test Method Validation, IQ, OQ, PQ, FAI) of new supplier manufactured components.
• Strong communication skills and ability to work well within a multidisciplinary team.
• Proficient with GD&T and interpreting technical drawings.
• Green or Black Belt Six Sigma certification preferred.

Requirements

• Process Validation & Quality Engineering (IQ/OQ/PQ, TMV, PFMEA, Gage R&R)
• Statistical Analysis & Six Sigma (SPC, DOE, MSA, Minitab)
• Medical Device Quality Systems (GMP, ISO 13485, FDA Compliance)
• Bachelor in Mechanical Engineering or equivalent and have min. 5 years' experience working as a Quality, Validation and or Manufacturing Engineering role in a Medical Product industry required.
• Required medical domain experience. Surgical Product and Implants experience preferred.