Quality Assurance Specialist: Regulated Medical Device Compliance
6 days ago
About Abbott Laboratories
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 AbbottAt 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.
This position works from our Missisauga office in the Abbott Diabetes Care (ADC) Division. In ADC, we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.
Key ResponsibilitiesYou will support Quality team in maintaining compliance with Canadian Medical Device Regulations; ensure the submission of Mandatory Medical Device Problem Reports to Health Canada are correct and timely; assist with maintaining effectiveness of Quality System as well as ensuring adherence to policies and procedures; using effective tools for tracking deadlines and follow up actions related to key Quality activities such as complaint management, CAPAs, Non-Conformances, Suppliers, as needed; represent QA in working with various functional teams to support non-complex business critical activities; support QA Manager in analyzing key Quality data for the purposes of the Management Review, as needed; take on various projects to assess compliance gaps and improve audit readiness.
RequirementsWe require a Bachelor's degree; 1-3 years of experience in a similar role; computer skills with proficiency with Microsoft Office applications (MS Word, Excel, Access, PowerPoint); equally effective in a team environment and independently; strong 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, written and presentation skills; maintains a focus on continuous quality improvement.
Preferred QualificationsWe prefer bilingualism (English and French); 1 to 3 years experience with data entry experience in a bilingual work environment handling patient health and customer information.
Estimated salary: $60,000 - $80,000 per year based on experience and qualifications.
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