SR Associate Quality Assurance- Abbott Diagnostics (mississauga)- 12 Month Contract

January 20 2021
Categories Bank, Insurance, Financial services, Production, Operations, Quality, Safety, Production, Operations, Quality, Safety, Quality assurance and control, Validation
Mississauga, ON

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 130 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 107,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.

Status: Contract (12 months), Full Time

Responsibilities:

  • 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.

  • 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 Canada’s 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.

  • Perform onsite or desk top evaluations as needed.

  • 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.

  • Quality holds, nonconformances, damages, recalled product, nonsalable goods.

  • Authorize returned goods as per written procedure.

  • Evaluate Temperature excursion impact on products as per procedure and give assessment as appropriate.

  • Manage product quarantines linked to Temperature Excursions or transportation issues by placing products on quarantine status, as required and communicate QA HOLD notifications as appropriate.

  • Provide input and assist Manager in any QA-related activities and keep him/her abreast of any activities that could negatively or positively impact products and/or processes.

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

  • Coordinate timely notification of Field Actions to customers and HC Inspectorate.

  • Maintain customer contacts list for quality communications.

  • Interact directly with the local Health Canada Compliance Officer to ensure Field Actions are executed effectively.

  • Provide timely notification of Mandatory Reports to HC Inspectorate Officials.

  • Provide timely notification of Product Information letters to customers.

  • Maintain customer contacts list for quality communications.

  • Quality Assurance personnel are held self-accountable for assigned tasks/projects.

  • Ensure that assigned key corporate goals are reviewed for completion within specified timelines.

  • In collaboration with manager, identify key impact goals and competencies to be addressed in the following year.

  • 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.

Education and Required Experience:

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

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

  • At least 5 years in Quality Assurance or another function in the 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 desirable.

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.

Our diversity goals for recruitment, hiring, and retention are embedded in our corporate goals, and our diversity initiatives are supported by the highest level of the organization.

We strongly believe that a diverse workforce fosters more creative and innovative thinking throughout the organization. Creating an inclusive environment, where everyone is respected and valued, enables us to leverage our diversity as a business driver and strengthens our position as a global leader.

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.

Apply now!

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