1+ months
2018-03-152018-05-13

Senior Quality Engineer

Abbott
Los Angeles, CA

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.

We are seeking an experienced, high caliber Senior Quality Engineer for Sylmar's Operations Quality Engineering team.
 
Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
 
 
Impact this role will have on Abbott:

  • 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
  • Support stability studies per drug/device combination product regulations
  • 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 methodologies (e.g., Six Sigma and Lean Manufacturing)
  • Lead the investigation, resolution and prevention of product and process non-conformances
  • 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


     
    Your experience(s), education and knowledge will further expand Abbott's marketplace success:

    • BS degree in Engineering or Technical Field or equivalent experience
    • 5+ years’ experience, 2+ of which should consist of drug or combination product experience
    • 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
    • Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
    • Ability to work in a highly matrixed and geographically diverse business environment
    • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
    • Ability to leverage and/or engage others to accomplish projects


      Your preferred qualifications and education:

      • Advanced degree preferred
      • Demonstrated supervisory experience preferred
        Job Family: Operations Quality
        Division: ASJM Abbott St. Jude Medical
        Travel: Yes, 10 % of the Time
        Medical Surveillance: No
        Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Senior Quality Engineer

Abbott
Los Angeles, CA

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Abbott
Los Angeles, CA
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