Quality Engineer

Katalyst CRO; Englewood (CO); On-site; USD 75,000 - 105,000; Full time

Job summary

Katalyst CRO is seeking a Quality Engineer/Inspector to perform incoming and first article inspections and ensure conformance to specifications and quality requirements. You will use precision measurement tools and review GD&T requirements to determine inspection methods.

Responsibilities include developing inspection plans, conducting Gage R&R and MSA studies, analyzing measurement data, and implementing improvements to reduce variation. Strong communication and analytical skills are essential.

Qualifications

• Bachelor’s degree in Engineering or related technical discipline; two years of experience preferred.
• Experience conducting Gage R&R studies, MSA, and statistical data analysis.
• Ability to interpret GD&T, drawings, and specifications.
• Knowledge of FDA QSR, ISO 13485, and quality standards.
• Strong communication, analytical, and organizational skills.
• Proficiency with Excel, Word, PowerPoint.

Responsibilities

• Perform incoming and first article inspections to verify conformance to specifications and quality requirements.
• Utilize precision measurement equipment to perform dimensional and visual inspections.
• Review drawings, specifications, and GD&T requirements to determine inspection methods and acceptance criteria.
• Develop, maintain, and improve inspection plans, sampling plans, and product acceptance standards.
• Plan, execute, analyze, and document Gage R&R studies and MSA activities.
• Evaluate measurement system performance and implement improvements.

Skills

Analytical skills

Problem-solving

Organizational skills

Written and verbal communication

Ability to work independently

Education

Bachelor's degree in Engineering or related technical discipline

Tools

Minitab

Microsoft Office

Job description

• Perform incoming and first article inspections of 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 review 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

Roles & Responsibilities

• Perform incoming and first article inspections of 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 review 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.