Quality Engineer - "Medical Device" Job at Fusion Life Sciences Technologies LLC, Englewood, CO

  • Fusion Life Sciences Technologies LLC
  • Englewood, CO

Job Description

Job Description

Title: Quality Engineer

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Duration: 6- 12 Months

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Location: Englewood, CO

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Essential Responsibilities and Duties

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

Work at office

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