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Senior Quality Assurance Engineer

1 month ago

Minnetonka, Minnesota, United States Abbott Full time
About the Role

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 114,000 colleagues serve people in more than 160 countries. For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive.

Key Responsibilities
  • Serves as liaison between internal Abbott third-party manufacturers and Abbott Vascular, ensuring effective implementation of quality and compliance requirements between multiple quality systems and sites.
  • Responsible for implementing and maintaining an effective Quality System, ensuring compliance with applicable Corporate and Divisional Policies and procedures.
  • Independently leads groups and projects to resolve complex issues, analyzing complex problems and identifying their impact, establishing probabilities, and drawing conclusions reflecting broad business needs.
  • Cross-functionally leads Quality System process improvements, including training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, and validation.
  • Responsible for completing documentation in a timely manner and in accordance with business standards.
  • Travel up to 10% of the time, both domestically and internationally, to support organizational goals.
  • Prepares metrics data and supports audit and audit readiness activities.
Requirements
  • Minimum Education: Bachelor's degree (Engineering/Life Sciences) plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience.
  • Medical Devices experience preferred.
  • Experience working with Quality Systems.
  • Data Analysis experience.
  • Risk Management experience.
  • Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices.
  • Ability to form and develop interpersonal, professional relationships and display socially and professionally appropriate behavior.
  • Ability to work independently and in groups, and ability to work cross-functionally.
  • Ability and aptitude to use various types of databases and other computer software.
  • Ability to prioritize and strong organizational and project management skills.
  • Ability or aptitude to lead without direct authority.
About Abbott

At Abbott, you can have a good job that can grow into a great career. We offer a fast-paced work environment where your safety is our priority, training and career development, financial security through competitive compensation, incentives, and retirement plans, health care and well-being programs, paid time off, and 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 makes Abbott an attractive place to work. Learn more about our benefits that add real value to your life to help you live fully.