Quality Systems Administrator/Project Manager

4 weeks ago

Fremont, California, 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.

As a Quality Systems Administrator/Project Manager, you will be responsible for managing, supporting, and maintaining division-wide Quality System applications (DMS/LMS) in compliance with ISO 13485 and other regulatory and industry standards for medical devices.

You will also manage projects, ensuring excellence in delivery of division and department projects. This includes identifying quality initiatives, providing influential leadership to drive proactive continuous Quality System improvements, and maintaining effective Quality metrics.

Key Responsibilities:

  • Manage and process system account requests for internal and external users
  • Maintain effective Quality metrics and define and execute activities to resolve decreases in performance
  • Represent Quality Systems in support of cross-functional divisional projects
  • Write and execute User Acceptance Testing (UAT) protocols
  • Serve as liaison to IT team to address and implement system and process updates
  • Create, analyze, and process change items in compliance with QMS, ISO 13485, business procedures, and other applicable standards

Requirements:

  • Bachelor's Degree in a related field or an equivalent combination of education and work experience
  • Minimum 5 years of experience in a combination of Quality Systems Administration and Project Management
  • Knowledge and experience with administration of validated Quality System (DMS/LMS) applications strongly preferred
  • Extensive knowledge of project management processes
  • Leadership and influencing skills
  • Sound business and technical acumen
  • Experience with stakeholder management
  • Ability to communicate at all levels with clarity and precision both written and verbally
  • Strong presentation skills
  • Ability to remove barriers and enable teams to complete their objectives
  • Excellent problem-solving and critical-thinking skills
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment

Abbott is an Equal Opportunity Employer, committed to employee diversity. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call or email.

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