- Responsible for the development of part specific quality plans based on customer requirements, in a manufacturing environment.
- Ensure compliance to ISO9001, ISO13485, AS9100 and FDA CFR820
- Bachelor's degree (Mechanical Engineering Preferred)
- Minimum 5 years exp working in the medical or aerospace manufacturing environment.
- Have a good understanding of GD&T as well as metrology, ability to read blueprints, and interpret to ANSI specifications.
- Must have a good understanding and ability to develop and document Risk Assessment, FMEA and Process Control Plans, CAPA activities.
- Candidate must have excellent communication, organization, time and project management, and computer skills.
- CQE, CQA, or Green Belt is a plus