Quality Engineer

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

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.