Cook Medical CAPA Engineer in bloomington, Indiana
The CAPA Engineer at Cook Inc. leads and facilitates improvement efforts across the company utilizing the Corrective and Preventive Action (CAPA) quality system process.
• Lead CAPA projects• Employ risk analysis tools to determine appropriate internal and external corrections required• Develop and employ sound investigative techniques to fully understand and document problems• Utilize, lead, and facilitate formal Root Cause analysis/techniques• Determine, verify, implement, and measure effectiveness of corrective actions• Thoroughly document all aspects of the CAPA process to develop an audit ready CAPA record• Interface with cross-functional teams throughout CAPA process to ensure effective outcomes• Determine training needs for changes implemented through the CAPA process
• Complete CAPAs in an efficient and effective manner in order to meet the company's metrics for the effectiveness of the CAPA process
Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) of this employment position.
• 4 year college degree in a technical discipline; or experience of such kind and amount as to provide a comparable background• Knowledge of Excel, PowerPoint, Word, and Visio
• Limited exposure to hazardous chemicals used in the manufacture of the product• Good manual dexterity• Proper attire/clothing and personal protective equipment/clothing, as required, within Controlled Production Areas
• Utilizes close visual acuity for working with computers, etc.• Moderate exposure to noise level in the work environment that is moderate to occasionally loud
Job Location(s)Bloomington IN United States
Position TypeFull Time