Senior Manager, Software Quality Validation

Company: Abbott Laboratories
Location: Lake Forest
Posted on: February 17, 2021

Job Description:

Senior Manager, Software Quality Validation 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. Manager, Software Quality Validation San Diego, Carlsbad, CA or Lake Forest, IL DO WORK THAT MATTERS The Rapid Diagnostics Division at Abbott is a part of our Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. The position of Manager, Software Quality Validation is within our Cardiometabolic Business Unit and can be based out of our Carlsbad, San Diego, CA or Lake Forest, IL operations. This is a first of its kind role for our CM BU and will be fundamental in managing resources for the Software Quality department, establishing department goals, developing and maintaining processes and procedures, and assuring adherence to the software development lifecycle across BU. In addition, this role will be responsible for driving consistency and strategy of Software Validation global and across the BU. RESPONSIBILITIES Develop, maintain and oversee the divisional software development and validation program. Develop and conduct training of company personnel for the divisional software development and validation program. Work with Design and Manufacturing Engineering in the completion of system / software requirements and other verification and validation processes. Create and execute or direct software validation protocols traceable to system/software requirements. Develop and implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems. Assist in the completion and maintenance of risk analysis, focused on software related risks. Design and implement various product and process improvement methodologies (ie Six Sigma and Lean Manufacturing). Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating, and resolving issues. Develops and manages department operating budget. Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment. 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. QUALIFICATIONS Bachelor's Degree in Engineering, preferably Manufacturing or Mechanical Engineering, and 7 years of related work experience IT or SW Validation is required Experience with Root Cause Analysis is required Relevant experience in Medical Device, Pharmaceutical, Nutrition or Semiconductor industry is required Quality Systems experience required Strong communication skills are required Demonstrated experience with data driven decision making skills is required Get tailored job recommendations based on your interests.

• JOB ID: 30969823
  • LOCATION United States - Illinois - Lake Forest
  • ADDITIONAL LOCATION United States - California - San Diego
  • DIVISION ARDx Abbott Rapid Diagnostics
  • TRAVEL Yes, 20 % of the Time
    • MEDICAL SURVEILLANCE No
      • SIGNIFICANT WORK ACTIVITIES Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Our business encompasses many different functions and capabilities, which allows you to explore careers in various fields.-- GROWTH PLANNING Growth Planning and Performance Excellence is an annual process through which you'll be able to have open career discussions with your manager to help you determine your own career path and future. TRAINING & NETWORKS We provide a wide range of classroom and e-learning courses to help you develop new skills and enhance your career.-- WE'RE RECOGNIZED AROUND THE WORLD DOW JONES SUSTAINABILITY INDEX BEST CORPORATE CITIZENS FORTUNE CHANGE ---------------------THE WORLD FORTUNE'S MOST ADMIRED COMPANIES JOIN OUR TALENT COMMUNITY We will notify you about relevant positions, and keep you in mind whenever we have interesting opportunities.-- Abbott welcomes and encourages diversity in our workforce including Minorities, Women, Individuals with Disabilities and Protected Veterans. We provide reasonable accommodation to qualified individuals with disabilities. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

Keywords: Abbott Laboratories, Lake Forest , Senior Manager, Software Quality Validation, IT / Software / Systems , Lake Forest, California