What are the responsibilities and job description for the Quality Engineer position at Katalyst CRO?
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
- 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.