Tipo de empleo: Full-time

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Contenido de trabajo

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

  • Career development with an international company where you can grow the career you dream of.

  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Ottawa, Ontario location in the Point of Care, Diagnostics division. 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 Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics and toxicology.

In this role you will support the QA Operations team in supporting the validation, CAPA and change control systems while overseeing production and process controls.

What You’ll Do

As an integral member of the Quality Operations team, you will work on products and processes to ensure that we maintain and continuously improve our quality management system, meet all regulatory requirements, and ensure that our products are safe and effective.

You will be involved in the Quality Operations team as well as with many cross functional teams that we support and assist. As part of your day to day work you will work on:

  • Keeping up to date with Good Manufacturing practices and with regulatory requirements for our industry and products.

  • Evaluating change control packages to ensure the changes made are appropriate and that equipment, products, processes, and facilities remain in qualified, validated state.

  • Assisting to structure the development of and approve qualifications and validations.

  • Review, and approve risk assessments for instruments, equipment, processes, and products.

  • Review and approve non-conformances and CAPA investigations as well as corrective actions. To ensure that investigations obtain root cause and that this results in implementation of robust corrective actions.

  • Analyze data and information to determine whether processes, equipment, and products are within an appropriate state of control during qualification and validation as well as in assessing the need for requalification / revalidation on a periodic basis.

  • Prepare and present quality metrics; attend cross-functional team meetings to share information.

  • Other duties as required.

  • Note – this is a shift position, working on A shift 4X4, rotating four days on, four days off from 6:30 am to 6:30 pm.

Required Qualifications

Typically requires 2+ years of related experience in (such as Quality, Compliance, Engineering) within a regulated environment.

Bachelor’s Degree in Science or Engineering with Biochemical or Chemistry focus, or equivalent.

Experience in the Medical device, diagnostics or pharmaceutical industries is preferred.

Previous experience with regulatory agencies is preferred.

Knowledge of ISO 13485; Knowledge of quality management techniques and the application and principles of quality engineering, strong knowledge and application of concepts, practices, and procedures.

Ability to convey communications clearly, concisely, and accurately

Ability to prioritize and handle multiple tasks

Ability to work independently and in groups ability to work cross-functionally

Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors

Ability and aptitude to use various types of databases and computer software

Strong organizational and project management skills


Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Abbott Canada is committed to the hiring, advancement, and fair treatment of individuals without discrimination based on factors such as race, sex, colour, ethnic or national origin, religion, disability, age, citizenship, family or marital status, political beliefs, sexual preference or other factors included in human rights legislation. Abbott strives to promote and maintain an inclusive, high-performing culture that allows all employees to reach their full potential and contribute to Abbott’s success. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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Plazo: 18-07-2024

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