Manufacturing Engineer II – CAPA

Abbott Laboratories
Published
November 26, 2021
Location
Pomona, CA
Category
Job Type

Description

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.

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of Manufacturing Engineer II is within our Toxicology Unit located in Pomona, California.  This role will provide support for completion of CAPA projects within Operations.  Develops, implements and maintains methods, operation sequence and processes in the manufacture or fabrication of parts, components, sub-assemblies and final assemblies.  Interfaces with design engineering in coordinating the release of new products. This position will partner with Quality for process improvement and continuous improvement initiatives. Maintains records and reporting systems for coordination of manufacturing operations.

This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES:

  • Resolve Quality Incidents (QI) and CAPA by performing investigations, conducting root cause analysis, developing and implementing plans to resolve.

  • Work closely with R&D, Manufacturing, Quality Control, Quality Assurance and Applications Support management to prevent non-conformities and provide solutions to complex issues.

  • Lead meetings and communications for CAPA updates, information and concerns

  • Applies basic understanding of FDA, ISO and cGMP theories and principles.

  • Contribute to Group’s objectives by carrying out assignments.

  • Supports current automated manufacturing equipment.

  • Ability to investigate and modify existing control systems and user interfaces

  • Write manufacturing work instructions, validation protocols and equipment specifications.

  • Collaborate with cross functional teams using various methodologies (e.g., Six Sigma root cause analysis/problem solving skills).

  • Supports design of experiments to improve understanding of impact of variability in manufacturing on downstream processes and aid in the development of improved manufacturing procedures and processes.

  • Supports the use of process mapping tools and manufacturing data to drive improvements in operational efficiencies and cost improvement initiatives.

  • Use of project management including vendor and interdepartmental interactions

  • Carries out duties in compliance with established business policies.

  • Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.

  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

  • May work with hazardous materials.

  • Perform other duties & projects as assigned.

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

  • BS degree in engineering or related field.

  • 3-5 years of experience in engineering role.

  • Minimum of 2 years hands-on CAPA experience with solid understanding of progression of CAPA investigations and other activities in a CAPA program.

  • Experience with computer applications include SolidWorks, AutoCAD, MS Word, Excel and Project. 

  • Verbal and written communication skills; Organized and detail oriented.

  • Ability to use MS Office and other manufacturing systems.

PREFERRED QUALIFICATIONS:

  • Basic knowledge of federal and other regulations governing medical device assembly and design, e.g., GMP, QSR, ISO and CMDR.

  • Understanding of machine function, mechanical/electrical or software engineering.

  • Knowledge of Lab View, PLC and other specialty machine and vision software.

  • Able to work with a variety of people on multiple projects; Ability to work independently and in a team environment.

  • Organized and detail oriented

  • Knowledge of structured problem-solving/lean tools.

COMPETENCIES:

  • Acts ethically and takes accountability for achieving outcomes.

  • Teamwork

  • Proactively listens to internal/external customers and clarifies expectations

  • Promptly and effectively handles issues and problems

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please contact your local HR department.

Only registered members can apply for jobs.

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