The Opportunity

This position is based at our Mississauga office within theCore Labdivision and requires onsite presence four days per week, with the option to work remotely one day. Were 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 Abbotts diagnostics instruments, providing lab results for millions of people. As the Sr Associate, Quality Assurance, youll have the chance to ensure Compliance to ISO 13485, CMDR, Abbott Corporate, Abbott Diagnostics Division, Abbott Diabetes Care, Abbott Molecular and Abbott Point of Care (Commercial) Quality policies and procedures.

What Youll Do

• Keep abreast of Canadian Medical Device Regulations (CMDR), ISO 13485 and related policies and guidelines with respect to GMP.

• Facilitate local site audits and provide support to manufacturer audits as needed. (ISO 13485 CMDCAS, MDSAP, Health Canada, FDA).

• Interact directly with Health Canadas Inspectorate to ensure compliance with the Food & Drugs Act & Regulations.

• Coordinate/ conduct annual internal audit.

• Provide quality compliance consultation as required, such as: Distributor selection and evaluation, third party logistics qualification and monitoring.

• Work with Manager to ensure Key Performance Indicators (KPIs) are met or exceeded.

• Maintain local Approved Supplier List (ASL) and coordinate/ conduct Supplier evaluations.

• Coordinate and execute the documentation change management process. Issue new or ensure revision and implementation of revised Quality procedures. Assess changes to Corporate, Division policies and Health Canada requirements and evaluate impact on local procedures.

• Maintain site specific quality documentation in a controlled database.

• Training administrator in Electronic Training Management System (ETMS).

• Ensure product conformance and approve final disposition.

• Maintain/ coordinate/ conduct Corrective and Preventative Action Plans.

• Challenge usual way of performing tasks, identify continuous improvement opportunities, review with QA Manager, implement and document.

• Collaborate with global affiliates across divisions to identify and implement continuous improvement and harmonization across the Abbott Quality Systems and incorporate Shared service where applicable.

Required Qualifications

• Bachelors degree in a scientific, technical, or compliance discipline is required.

• Experience with Canadian Medical Device Regulations (CMDR) and ISO audits

• At least three to five years in Quality Assurance or another function in pharmaceutical, medical device, nutritional or related industry experience.

• Have complete knowledge of Quality Systems and Regulatory Science

• One or two years in Compliance or Regulatory Affairs is preferred.

The annual base salary for this position ranges from $75,750.00 to $111,100.00 CAD. The salary range provided applies to Canada only and does not apply to any other locations outside of Canada.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.