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Quality Engineer- Casa Grande Plant

Location: Casa Grande, AZ
Company: Abbott
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Job Description
The Quality Engineer is involved in all aspects of the manufacturing operation from assessing equipment needs, to documenting installation, qualification, and ongoing validation of equipment and processes. The Quality Engineer is also expected to assist in the identification and resolution of quality related issues and work with other areas to resolve issues.
Responsible for implementing and maintaining the effectiveness of the quality system.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Review RCEs, Validation documents, Preventative Maintenance & Calibration records to identify impact to quality aspects, GMP and potential product hazards.
- Contribute to development of appropriate process designs and validation protocols; assist in the design and execution of validation protocols when required.
- Assist in the development and performance of process capability studies on manufacturing equipment. Work with equipment reliability teams on process improvements.
- Assist in development and implementation of quality and productivity improvement projects.
- Provide Quality Assurance input to the change control program and maintenance of the Validation Master Plan. Perform periodic reviews.
- Assist in exception report root cause analysis, exception report trending and problem identification and resolution on Quality Assurance and Validation projects.
- Perform HACCP GMP, IFA, cross connection / backflow, SQF validation / verification and other quality and compliance audits as required.
- Ensure updates are made to the HACCP and Food Safety Plans based on impact of changes in the plant from a Hazard Assessment & Risk based approach.
Minimum of 8 years in a manufacturing environment with emphasis on Quality. Technical knowledge of food manufacturing equipment, processes and procedures.
Minimum 4+ years of technical experience in a manufacturing organization with a Bachelor's or Master's Degree in Science (preferably Manufacturing, Engineering or other related disciplines)
Must have HACCP and PCQI certifications.
Knowledge of Statistical processes and requirements
- 4 years' experience /knowledge of Food Manufacturing, HACCP, FSMA regulations, Low Acid Food regulations, Infant Formula regulations, Aseptic processing and other requirements such as Kosher and Halal.
- 4 years working with statistical tools and problem solving. Must have strong computer technical skills, data analysis.
- Must be able to work and influence cross functional teams, self-motivated, design to solve problems and drive programs/teams to completion.
The Quality Engineering will assure that they support Abbott projects in order to meet schedule and start-up dates
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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