Quality Engineer

Quality Engineer

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.