Manufacturing Engineer

Company: HumCap Recruiting
Location: Richardson
Posted on: May 28, 2023

Job Description:

POSITION SUMMARYThe Manufacturing Engineer will play a key role in building and advancing system processes and designing quality assurance measures for the creation of custom orthodontic solutions. - This will include documenting and defining current processes, as well as designing new ones to generate efficiency, repeatability, and control in the production and R&D cycles. - Most importantly, this role will define and execute QA steps within a Quality Management System to ensure the product is safe, complete, and ready for application by the end user. -RESPONSIBILITIES

• Compile, organize, and formalize process documentation for a Quality Management System
• Maintain and improve the quality system through regular updates, training, and audits
• Implement 21 CFR 820 and ISO 13485 standards into the process with the end goal of FDA clearance
• Design and execute QA measures at critical steps in the process, both digitally and in the fabrication lab
• Receive, track, and resolve support tickets and customer complaints related to the product and lab process -QUALIFICATIONS
  • B.S. in Engineering or equivalent applicable experience
  • 2+ years' experience in Quality Control, Quality Assurance, or similar field preferred
  • Previous experience with Lean 6-Sigma, cGMP, and ISO standards, 9001 and/or 13485
  • Design verification and validation
  • Excellent written and verbal communication skills-technical writing experience and ability to teach quality systems
  • Strong knowledge of Microsoft Excel and other Office applications
  • Team lead experience

Keywords: HumCap Recruiting, Richardson , Manufacturing Engineer, Other , Richardson, Texas