Quality Engineer

Katalyst CRO; Englewood (CO); On-site; USD 65,000 - 90,000; Full time

Job summary

Katalyst CRO in Colorado is seeking a detail-oriented Quality Engineer focused on inspection and measurement analytics. You will perform incoming and first article inspections, review specs, and apply GD&T to determine acceptance criteria in a highly regulated manufacturing environment.

The role requires experience with Gage R&R, MSA, and statistical tools like Minitab, plus strong communication and documentation skills.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• Experience with Gage R&R, MSA, and data analysis.
• Skilled in interpreting drawings and GD&T requirements.
• Experience with FDA/ISO quality standards preferred.

Responsibilities

• Perform incoming and first article inspections to verify conformance to specifications and quality requirements.
• Use precision measurement equipment to conduct dimensional and visual inspections.
• Review drawings and GD&T to determine inspection methods and acceptance criteria.
• Develop and maintain inspection and sampling plans and product acceptance standards.
• Plan and document Gage R&R studies and MSA activities to ensure measurement system capability.
• Evaluate measurement system performance and implement improvements to reduce variation.
• Collaborate with cross-functional teams in a fast-paced regulated environment.

Skills

Gage R&R

MSA

Statistical data analysis

Minitab

GD&T interpretation

Dimensional inspections

Precision measurement equipment

Quality engineering

Communication skills

Microsoft Office (Excel, Word, PowerPt

Education

Bachelor's degree in Engineering or related technical discipline

Tools

Minitab

Calipers

Micrometers

Height gauges

Optical comparators

Keyence

Job description

Roles & Responsibilities

• Perform incoming and first article inspections to verify conformance to specifications and quality requirements.
• Utilize precision measurement equipment including calipers, micrometers, height gages, optical comparators, Keyence, and other inspection tools to perform dimensional and visual inspections.
• Review engineering drawings, specifications, and Geometric Dimensioning and Tolerancing (GD&T) requirements to determine appropriate inspection methods and acceptance criteria.
• Develop, maintain, and improve inspection plans, sampling plans, inspection procedures, and product acceptance standards.
• Plan, execute, analyze, and document Gage Repeatability and Reproducibility (Gage R&R) studies and other Measurement System Analysis (MSA) activities to ensure measurement system capability.
• Evaluate measurement system performance and implement improvements to reduce measurement variation and improve inspection effectiveness.
• Other duties as assigned.

Requirements

• Bachelor's degree in Engineering or a related technical discipline, two years of experience preferred.
• Experience conducting Gage R&R studies, Measurement System Analysis (MSA), and statistical data analysis.
• Working knowledge of statistical tools and software, including Minitab or equivalent applications.
• Experience performing dimensional inspections and utilizing precision measurement equipment.
• Ability to interpret engineering drawings, specifications, and Geometric Dimensioning and Tolerancing (GD&T).
• Knowledge of inspection methodologies, sampling plans, and quality engineering principles.
• Understanding of FDA Quality System Regulations, ISO 13485 requirements, and other applicable quality standards preferred.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication skills with the ability to effectively communicate technical information.
• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.
• Ability to work independently and collaboratively in a fast‑paced, regulated manufacturing environment.
• ASQ Certified Quality Engineer (CQE) preferred.