Quality Engineer - Round Lake, IL

Responsibilities:

• Must have experience or advanced training and demonstrate proficiency in change controls, Investigations, problem solving, statistical methods, DHF remediation, Risk file remediation, problem analysis and resolution, materials science, design of experiments etc.
• Good understanding of EUMDR remediation; extensive cross-functional team experience, including technical and non-technical work.
• Completely proficient in relevant products development processes in compliance with FDA design control 21CFR820.3 and ISO13485
• Understanding 21CFR600 is also preferred
• Act independently with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on recent technical knowledge.
• Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.
• Ability to manage routine small projects without assistance.

Qualifications:

• BS in Engineering (discipline: Mechanical, Biomedical preferred)
• 3-5+ years of recent and relevant experience
• Design Control Elements
• Risk Management Elements
• Software: Trackwise8 proficiency, Word, Excel, Visio, PowerPoint, Outlook
• Change Control TW8 system experience
• Preferences: good communication skills written and spoken

Skills:

• Team Player
• Good Communicator