Position Overview:

• This position supports design transfer activities and quality operations in an innovative, fast-paced, medical device-manufacturing environment.


• This role includes generation and maintenance of control plans, risk management files, validation protocols, and other QMS documentation to support initial qualification and launch of commercial production activity.
• The role will also provide support to the organizational goals by leading improvement projects to increase efficiency and compliance across the site.

Responsibilities:

• Leverage your engineering and technical experience to evaluate new products, manufacturing processes and ensure compliance with applicable regulatory standards throughout the New Product Introduction process Provide input to the development, review, and update of User Requirements, critical quality attributes, and other design documentation Lead project teams through valid...