Quality Engineer supports all aspects of the Quality Management System, Product Realization and Manufacturing Process Controls. Working with cross functional partners, defines and generates quality control plans, production process controls and procedures. Leads and supports validations including statistical analysis. Engages with customers to address quality issues and define acceptance criteria/attributes.

Essential Job Functions and Responsibilities

• Support the development and manufacturing of medical devices in conformance with applicable ISO 13485 requirements. Responsible for quality planning of all new development programs and design transfers to production.
• Ensure policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.
• Interact and form constructive working relationships with all levels of leadership within Quality, Procureme...