Job Description
Mechanical Quality Engineer supporting new product development. Develop, improve, and implement quality methods and systems, working on cross functional teams in a regulated environment to ensure the safety, reliability and efficacy of products and processes.
Essential Duties and Responsibilities
- Support New Product Development as primary QE for mechanical implants and instruments. Manage multiple concurrent major and minor projects.
- Support Design Controls to ensure efficient, effective, and compliant new product launches.
- Support the qualification of legal manufacturers (OEM) for distributed products.
- Lead Material Review Board (MRB), own Non-Conformance (NC) development and resolution, lead reworks and deviations, participate in Supplier Review Board (SRB).
- Develop inspection plans and custom gauging based upon required measurement and tolerances.
- Support Change Order review for drawings, consid...