Quality Engineer I

AbbottLos Angeles, CA
78d$72,100 - $114,700

About The Position

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

Requirements

  • Bachelors Degree or an equivalent combination of education and work experience.
  • Engineering degree preferred.
  • Entry level position in which 0-2 years of experience is typical to meet the skills and responsibilities of the position.
  • Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices.
  • Knowledge of ISO 13485 standard.
  • Knowledge of quality management techniques and application.
  • Ability to clearly, concisely and accurately convey communications.
  • Ability to form and develop interpersonal, professional relationships.
  • Display socially and professionally appropriate behavior.
  • Ability to work independently and in groups.
  • Ability to work cross-functionally.
  • Demonstrated initiative and problem-solving skills.
  • Critical-thinking skills.
  • Ability or aptitude to use various types of databases and other computer software.
  • Strong organizational skills.
  • Ability to prioritize.
  • Ability to multitask.
  • Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives.
  • Ability to quickly gain knowledge, understanding or skills and is willing to learn.

Responsibilities

  • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
  • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Design and conduct experiments for process optimization and/or improvement.
  • Appropriately document experiment plans and results, including protocol writing and reports.
  • Lead process control and monitoring of CTQ parameters and specifications.
  • Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
  • Lead the investigation, resolution and prevention of product and process nonconformances.
  • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
  • Lead in the completion and maintenance of risk analysis.
  • Work with design engineering in the completion of product verification and validation.
  • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • May assist in the training of personnel as directed by management.

Benefits

  • Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • Excellent retirement savings plan with high employer contribution.
  • Tuition reimbursement.
  • Freedom 2 Save student debt program.
  • FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

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What This Job Offers

Job Type

Full-time

Career Level

Entry Level

Education Level

Bachelor's degree

Number of Employees

5,001-10,000 employees

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