Abbott Sr. Quality Engineer in Irvine, California

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.


  • 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

  • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements

  • Lead, coach, and mentor non-exempt and entry level exempt personnel

  • 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 methodoligies (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.

  • Performs other related duties and responsibilities, on occasion, as assigned.


  • BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred

  • 5+ years experience

  • Demonstrated supervisory experience preferred

  • Engineering experience and demonstrated use of Quality tools/methodologies

  • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971

  • Solid communication and interpersonal skills

  • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner

  • Advanced computer skills, including statistical/data analysis and report writing skills

  • Prior medical device experience preferred

  • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)

  • ASQ CQE or other certifications preferred

  • Experience working in a broader enterprise/cross-division business unit model preferred.

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