CAPA Engineer

Posting Date 3 weeks ago(2/12/2021 5:14 PM)
Requisition ID
2021-8530
Job Location(s)
Bloomington IN United States
Shift Type
First
Position Type
Full Time
Company
Cook Inc.
Category
Engineering

Overview

The CAPA Engineer is responsible to lead and facilitate improvement efforts across the company utilizing the Corrective and Preventive Action, CAPA, quality system process.

Responsibilities

- 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
minimal supervision.
- Ability to remain calm and receptive in fast paced situations.

Qualifications

- BS in Engineering or related technical discipline.
- Proficient in Microsoft Word/Excel/Outlook/PowerPoint/Visio.

 

Physical Requirements:

- 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.

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