• Design Control Specialist

    Abbott Scarborough, ME 04074

    Job #2396841467

  • 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 113,000 colleagues serve people in more than 160 countries.

    Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.

    Abbott's life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.

    Our location in Scarborough, Maine, currently has an opportunity for a Design Control Specialist. In this role you'll be responsible for assisting in the implementation and maintenance of an effective Quality System.


    • Manage document implementation in QMS System and communicate approved changes to all team members

    • Ensure documents critical to quality have been successfully and correctly integrated into QMS system

    • Support Project Managers in confirming that proper design control and phase gate deliverables occur where required, e.g., signoffs are scheduled and completed, dependent deliverables are completed, phase plans are completed and agreed to by project leads before the phase starts

    • Build and maintain trackers and dashboards to capture and track metrics to clearly communicate status of multiple parallel workstreams

    • Drive continuous improvement and optimization of metric tracking and templates

    • Support cross functional project teams comprised of R&D, QA, RA, Marketing, and Manufacturing

    • Proactively monitor execution of tasks and deliverables in an effective manner

    • Appropriately escalate issues to the project teams and PMO Director when necessary

    • Contribute to the development and integration of product or process requirements



    • Minimum 2 years' experience in medical device / diagnostic industry

    • Bachelor's degree in science, engineering or other technical field (Bachelor's degree in non-technical field may be considered for candidates with significant on-the-job technical experience)


    • Understanding of product life cycle management and design control

    • Experience in Agile, Sharepoint, MS Teams preferred

    • Ability to effectively communicate at the management level

    • Understands and enforces Quality System requirements

    • Strong motivation and ability to self-start

    • Proven ability to work and build relationships cross functionally

    • Strong analytical and problem-solving skills


    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

    • Production areas that are clean, well-lit and temperature-controlled

    • 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 ~~~/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

    An Equal Opportunity Employer

    Abbot welcomes and encourages diversity in our workforce.

    We provide reasonable accommodation to qualified individuals with disabilities.

    To request accommodation, please call ~~~ or email ~~~

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