Quality Engineer

Quality Engineer

Requirements

• Bachelor’s Degree or higher in Sciences and/ or Engineering from an accredited university
• High School Diploma/GED and minimum of 4 years of engineering experience in a manufacturing, quality, laboratory and/or production environment

Responsibilities

• Maintaining product design intent as components, processes, methods, and specifications change, which includes product testing to verify and validate design of products and developing specifications and associated test methods.
• Initiating and completing technical activities to improve products, processes, or systems using continuous improvement methods and tools, such as: Six Sigma, PPU (Product and Process Understanding), Design of Experiments, CQI (Customer Quality Index) and Quality at the Source.
• Identifying quality improvements through monitoring and trending of key quality characteristics.
• Leading quality investigations, material disposition, and supply projects.
• Demonstrate/document/maintain product regulatory, ISO, and industry standards compliance.

Preferred Qualifications

• Bachelor’s degree in Microbiology, Biochemistry, Biology, Chemistry, Chemical Engineering from an accredited institution
• Medical device and/or quality management system experience such as Food and Drug Administration (FDA) Quality System Regulation (QSR) and/or International Organization for Standardization (ISO) 13485
• Working knowledge of root cause analysis tools and techniques
• Able to thrive within a multi-functional product team (Quality, Manufacturing, Tech Service, Marketing, Clinical, Regulatory, etc.)
• Strong written and verbal communication skills with a focus on technical writing
• Able to coordinate multiple tasks/projects and manage priorities accordingly