Quality Engineer

A Quality Engineer is responsible for ensuring products and manufacturing processes meet quality standards, regulatory requirements, and customer expectations. This role supports product development, manufacturing, supplier quality, and continuous improvement initiatives by implementing quality systems, conducting risk assessments, analyzing data, investigating nonconformances, and driving corrective and preventive actions (CAPA).

• 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.
• 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