Quality Assurance Associate

3 weeks ago

Mississauga, Canada Abbott Laboratories Full time

**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 Mississauga location in the Vascular Division. Abbott Vascular provides innovative, mínimally invasive, and cost-effective products for treatment of vascular disease.

**WHAT YOU’LL DO**
- Review, assess and submit complaints to Health Canada per the Canadian Medical Device Regulations in alignment with Business Unit Product Performance Group and Internal Abbott requirements;
- Participate in the execution and follow-up with recalls/field action management;
- Support internal and external audits (AAAP, MDSAP, Health Canada, etc);
- Support the Correction and Preventive Action (CAPA) system;
- Support the Supplier and Distributor Management system process;
- Assist with preparation of Management Review and routine reports;
- Support of document control and training activities;
- Ongoing review of QMS documents and review where necessary;
- Provide employee training for applicable quality requirements including but not limited to Complaint Management, Internal SOPs and local instructions;
- Assist with Quality Improvement Initiatives across the organization where required;
- Other tasks as assigned by Manager.

**REQUIRED QUALIFICATIONS**
- Bachelor’s Degree required.
- 1-3 years of experience in a similar role.
- 1-3 years working in a health sciences industry.
- Proefficient in English and basic knowledge of French.
- Computer skills and proficiency with MS Office.
- Work equally effectively in team and independently.
- Decision making abilities.
- Time management skills and ability to multi-task.
- Mindful and respectful of the confidential nature of information regarding patients, customers and the business of Abbott Medical Canada.
- Effective verbal and written presentation skills.
- Maintain a focus on continuous quality improvement.
- Takes business approach to problem solving.
- Familiar with confidentiality requirements as they pertain to personal health information.
- Knowledge of Canadian Medical Device Regulations.

**PREFERRED QUALIFICATIONS**
- Completion of Regulatory Certification Program.
- Previous experience in medical device and/or cardiology.

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.

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