Quality Engineer 1

Fusion Life Sciences; Englewood (CO); On-site; USD 65,000 - 78,000; Full time

Job summary

Fusion Life Sciences in Englewood, CO is seeking a Quality Engineer 1 to support incoming and first article inspections, verify conformance to specifications, and uphold quality standards in a fast-paced, regulated manufacturing environment.

You will use precision measurement tools, review GD&T, develop inspection plans, and perform Gage R&R and MSA studies, with opportunities to grow ASQ CQE. Bachelor's in engineering and 2 years preferred.

Qualifications

• Bachelor's degree in Engineering or related technical discipline; 2 years experience preferred.
• Experience with Gage R&R, MSA and statistical data analysis.
• Working knowledge of statistical tools and software (Minitab or equivalent).
• Experience performing dimensional inspections with precision measurement equipment.
• Ability to interpret engineering drawings and GD&T.
• Knowledge of inspection methodologies, sampling plans and quality engineering principles.
• Understanding of FDA Quality System Regulations, ISO 13485 and other standards preferred.
• Strong analytical, problem-solving and organizational skills.
• Excellent written and verbal communication; proficient in MS Office.
• Ability to work independently in a regulated manufacturing environment.
• ASQ CQE preferred.

Responsibilities

• Perform incoming and first article inspections to verify conformance to specifications and quality requirements.
• Use precision measurement equipment to perform dimensional and visual inspections.
• Review drawings, specifications, and GD&T requirements to review inspection methods.
• Develop, maintain, and improve inspection plans, sampling plans, inspection procedures, and product acceptance standards.
• Plan, execute, analyze, and document Gage R&R and MSA studies to ensure measurement system capability.
• Evaluate measurement system performance and implement improvements to reduce variation.
• Other duties as assigned

Skills

Gage R&R

MSA

Statistical analysis

GD&T

Inspection planning

MS Excel

Documentation

Communication

Education

Bachelor's degree in Engineering or related technical discipline

Tools

Minitab or equivalent

Job description

Job Title: Quality Engineer 1

Location: Englewood, CO

Contract: 06/22/2026 - 04/30/2027

Reports To

Associate Manager of Quality - Production

Essential Responsibilities and Duties

• 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

Qualifications

• 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.