Quality Engineer

Katalyst-Healthcares-; 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

Summary:

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's 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.