Senior Quality Engineer - Medical devices

Job Title : Senior Quality Engineer

Job Location : Sturtevant, WI

Job Type : 5+ Months contract

This position is responsible for providing Quality Engineering and Technical Support for Operations, Sustaining Engineering, R&D, and New Product Introductions. This position would include supporting a wide array of activities related to Change Control, NCR / CAPA, Quality Operations, Design Control, New Product Development, Risk Management and Post Market Surveillance. This position would evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are needed. Provide direct support to Quality personnel regarding operation of the department and Quality System. Provide support to other departmental activities as directed.

Job Responsibilities :

Change Control :

• Review change requests and identify impact on product design and documentation
• Support Change Control Activities (Operations, Engineering, Design, etc.)
• Support updates to manufacturing procedures, process, product / specifications, risk management files, etc. through the Change Control process
• Support 3rd party supplier management activities such as review 3rd party design control activities

Design Control / Documentation :

Quality initiatives :

Support NCR and CAPA :

Risk Management :

Inspections :

Adherence to regulations :

Skills & Experience Required :