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Quality Engineer II

Company: Abbott Laboratories
Location: Minneapolis
Posted on: April 10, 2021

Job 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.About Abbott STRUCTURAL HEARTOur business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care. WHAT YOU'LL DOThis position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. Job Duties:

  • 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
  • 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
  • Appropriately document validation plans and results, including protocol writing and reports
  • 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
  • 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. EDUCATION AND EXPERIENCE YOU'LL BRING
    • BS degree in Engineering or Technical Field or equivalent experience;
    • 0-2 years experience
    • Engineering experience and demonstrated use of Quality tools/methodologies
    • Knowledge of FDA, GMP, ISO 13485, and ISO 14971
    • Solid communication and interpersonal skills
    • Prior medical device experience preferred
    • 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.
    • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
    • Multitasks, prioritizes and meets deadlines in timely manner.
    • Strong organizational and follow-up skills, as well as attention to detail.
    • Ability to maintain regular and predictable attendance. WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:
      • Training and career development, with onboarding programs for new employees and tuition assistance
      • Financial security through competitive compensation, incentives and retirement plans
      • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
      • Paid time off
      • 401(k) retirement savings with a generous company match
      • The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at and on

Keywords: Abbott Laboratories, Minneapolis , Quality Engineer II, Engineering , Minneapolis, Minnesota

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