Bachelor's degree in Engineering or related technical discipline, with a preference for two years of experience.
Familiarity with Gage R&R studies and Measurement System Analysis (MSA).
Proficient in statistical tools/software, notably Minitab or similar applications.
Experience in dimensional inspections and using precision measurement instruments.
Ability to interpret engineering drawings and GD&T standards.
Knowledge of inspection methodologies and quality engineering principles.
Understanding of FDA Quality System Regulations and ISO 13485 standards is preferred.
Strong analytical and problem-solving abilities, with excellent communication skills.
Responsibilities
Conduct incoming and first article inspections to ensure compliance with specifications.
Utilize precision measurement equipment for dimensional and visual inspections.
Review engineering drawings and standards to determine inspection methods.
Develop and enhance inspection plans, procedures, and product acceptance standards.
Plan and document Gage R&R studies and Measurement System Analysis activities.
Assess measurement system performance and implement improvements.
Perform additional tasks as needed.
Benefits
Opportunities for career advancement and professional development.
Exposure to regulated manufacturing environments which offers unique experience.
Engagement with cutting-edge inspection technologies and methodologies.
Full Job Description
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.
bility 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.
bility to work independently and collaboratively in a fast-paced, regulated manufacturing environment.
