CAPA Engineer

Location

Winston Salem, NC | United States

Job description

The primary purpose of this position is to organize and coordinate the root cause analysis investigations and implementation of Corrective and Preventive Actions for active CAPA projects.

- Independently lead CAPA Investigations, including completing thorough root cause investigations related to medical device design and manufacturing, and Quality System processes.
- Determine implementation dates and provide documentation to support effectiveness of proposed corrective and preventive actions.
- Independently facilitate communication with CAPA sponsors and related stakeholders
- Document CAPA using CAPA software program(s).
- Independently interface with cross-functional teams to complete CAPAs in an efficient and effective manner per established CAPA timeliness and effectiveness goals
- Generate pertinent documentation relating to the product and manufacturing modifications
- Coordinate building and test prototypes of device modifications

- Provide training to assembly personnel during the introduction of a product or process modification.
- 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 oral and written communication skills
- Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
- Ability to remain calm and receptive in fast paced situations
-Perform other duties as assigned.

- 4 year college degree in a technical discipline and 3 years of prior relevant experience. Advanced degrees (Masters or PhD) in an Engineering discipline may reduce the years of experience requirement.

- Self motivated with the ability to work independently and in a team.
- Excellent oral and written communication and organizational skills.
- Knowledge of Excel, PowerPoint, Word, and Visio.

Physical Requirements:

- Must be able to perform the essential functions of the job, with or without reasonable accommodations.
- Limited exposure to hazardous chemicals used in the manufacture of the product.
- Good Manual dexterity

**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.**

“We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.”

Job tags

Salary