The CAPA Engineer is responsible to lead and facilitate 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.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with
- Ability to remain calm and receptive in fast paced situations.
- BS in Engineering or related technical discipline.
- Proficient in Microsoft Word/Excel/Outlook/PowerPoint/Visio.
- Works under general office environment conditions.
- Utilizes close visual acuity for working with computers and equipment.
- Frequently required to sit, stand, walk, and communicate.
- Personal protective equipment including safety glasses, lab coat and gloves may be required in some areas associated with this position.
- Limited exposure to hazardous chemicals used in the manufacture of the product.
- Moderate exposure to noise level in the work environment that is moderate to occasionally loud.
- Good manual dexterity.
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.
**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) for this employment position.