Quality Engineer - "Medical Device"

Job Description

Title: Quality Engineer

Duration: 6- 12 Months

Location: Englewood, CO

Essential Responsibilities and Duties

\n
• Perform incoming and first article inspections of to verify conformance to specifications and quality requirements.
\n
• Utilize precision measurement equipment including calipers, micrometers, height gages, optical comparators, Keyence, and other inspection tools to perform dimensional and visual inspections.
\n
• Review engineering drawings, specifications, and Geometric Dimensioning and Tolerancing (GD&T) requirements to review appropriate inspection methods and acceptance criteria.
\n
• Develop, maintain, and improve inspection plans, sampling plans, inspection procedures, and product acceptance standards.
\n
• 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.
\n
• Evaluate measurement system performance and implement improvements to reduce measurement variation and improve inspection effectiveness.
\n
• Other duties as assigned
\n \n
• Qualifications
\n
• Bachelor's degree in Engineering or a related technical discipline, two years of experience preferred.
\n
• Experience conducting Gage R&R studies, Measurement System Analysis (MSA), and statistical data analysis.
\n
• Working knowledge of statistical tools and software, including Minitab or equivalent applications.
\n
• Experience performing dimensional inspections and utilizing precision measurement equipment.
\n
• Ability to interpret engineering drawings, specifications, and Geometric Dimensioning and Tolerancing (GD&T).
\n
• knowledge of inspection methodologies, sampling plans, and quality engineering principles.
\n
• Understanding of FDA Quality System Regulations, ISO 13485 requirements, and other applicable quality standards preferred.
\n
• Strong analytical, problem-solving, and organizational skills.
\n
• Excellent written and verbal communication skills with the ability to effectively communicate technical information.
\n
• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.
\n
• Ability to work independently and collaboratively in a fast-paced, regulated manufacturing environment.
\n
• ASQ Certified Quality Engineer (CQE) preferred.
\n