Quality Engineer (1st shift)
Bachelor’s degree in Engineering and a minimum of 5 years’ experience working in the medical industries preferred. Ensure compliance with ISO9001, ISO13485, AS9100, and FDA CFR820. Responsible for the development of part-specific quality plans based on customer requirements in a fast-paced manufacturing environment. Experience with metrology, a hands-on engineer. Have a good understanding of GD&T, ability to read blueprints and interpret to ANSI specifications. This is also a customer-facing quality role; should have good communication skills – oral & written. Must have a good understanding and ability to develop and document Risk Assessment: FMEA and Process Control Plans, CAPA activities. Candidate should have a basic statistical background, organizational and computer skills.