The Senior Hardware Quality Engineer will be responsible for providing quality support, guidance and direction for all manufacturing facilities as well as improving quality systems capability and product quality. This position also requires the individual to assure conformance with regulations of the FDA and other international regulatory agencies while also being able to review and troubleshoot product and process specifications and procedures. A vast variety of data sources such as product review, global complaints, manufacturing quality data, etc, will need to be utilized in order to identify major trends and risks. The Quality Engineer will also need to work cross-functionally with other teams to improve current product design and introduce new products to the market.
- Minimum of 5 years experience within Quality Engineering
- 3 years of experience in the Medical Device industry
- Background in Design Controls, Verification and Product Development
- Management and Supervisory experience or experience leading others or holding leadership roles
- A working knowledge of statistics and practical application
- Demonstrated knowledge of Quality Management Systems (Design Controls, CAPA, Complaints, Document Control, etc)
For immediate consideration, apply online now or for further information, please contact Becky Krage at 312-453-9077.
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