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    Quality Assurance and Regulatory Affairs Associate – Co-op Student | Winter 2022

    Job Summary

    As a Quality Assurance and Regulatory Affairs (QA/RA) Co-op, you will support the continuous development, implementation, and improvement of NERv’s Quality Management System as well as provide support in preparing materials for communications/submissions with regulatory bodies. This includes working with both the QA/RA Manager as well as the development and manufacturing teams. This position will require you to come into our offices located in Kitchener, ON, as required.

    Job Responsibilities

    • Develop processes and draft standard procedures/work instructions in collaboration with relevant teams
    • Assist teams with proper implementation of procedures
    • Inspect and evaluate implemented procedures and practices including effectiveness of the process/workflow and potential optimization, as well as compliance to applicable regulatory and industry standards
    • Review, analyze, and report on quality discrepancies related to device systems and assembly process
    • Help develop and implement corrective and preventive actions for recurring discrepancies.
    • Ensure the completion of preventive maintenance and verification procedures of production equipment
    • Support in compilation of materials and documentation required for regulatory communications
    • Assist in maintaining a constant state of readiness for industry audits.

    Required Skills

    • Passion for delivering high quality products
    • Excellent written and verbal communication skills
    • Experience in extensive writing, reviewing, and editing of written material
    • Understanding of industry standards/ reading and navigating legal-style documents
    • Organized with high attention to detail
    • Quality-conscious mindset
    • Strong problem identification and problem resolution skills
    • Flexibility and ability to adapt to changing priorities
    • Excellent team player
    • Ability to work independently
    • High level of integrity and accountability
    • Experience in GMP, GDP, and/or GLP practices preferred (Preferred)
    • Understanding of Quality Systems structure and requirements (Preferred)
    • Knowledge of continuous improvement tools and statistical process assessment (Preferred)
    • Familiarity with medical device manufacturing processes (Preferred)
    • Familiarity with Health Canada’s and FDA’s medical device regulations (Preferred)