Description
The Senior Quality Engineer would be responsible forensuring products are developed and manufactured, utilizing the appropriate processes to ensure product quality. This role also requires working with other teams to understand product performance and improve quality systems capability. The Quality Engineer will need to make sure that the potential product and process risks are evaluated and corrected and comply with FDA, GxP and ISO standards. The individual who fills this role will need to monitor product data to identify statistically significant trends and risks while also utilizing a wide variety of data sources including product review, global complaints, and manufacturing quality data, etc..Candidate Requirements:
- Minimum of 5 - 10 years experience in quality, product design or product engineering in the medical device industry
- Background in Risk Management and Analysis
- Knowledgeable on FDA, GxP and ISO regulations and the ability to provide compliance guidance concerning the development and implementation of quality standards in regards to product development.
- Experience in Design Controls, CAPA, Complaints, Document Control, etc…
Preferred Requirements:
- Certification and/or license in specific discipline is desired (e.g. CQE)
- Experience in electro-mechanical/serialized devices
For immediate consideration, apply online now or for further information, please contact Becky Krage at .
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Looking forward to hearing from you!