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Kitchener

    Quality Assurance - Kitchener, Canada - Intellijoint Surgical

    Intellijoint Surgical
    Intellijoint Surgical Kitchener, Canada

    2 weeks ago

    Default job background
    Full time (In-office presence required 3-days per week)
    Description

    The Position

    The QA/RA Coordinator will support design, production, and process quality. You will contribute to the maintenance of the quality system, ensuring compliance to industry standards and regulatory requirements. The successful candidate will ensure that Intellijoint Surgical products are safe and effective.

    As a snapshot, we are looking for someone who:

  • Is very detail oriented, organized and diligent in adhering to policies and procedures
  • Is able to pivot their focus and "switchgears" to a new task, when priority asks arise
  • Has effective and clear written and verbal communication skills
  • Has experience working in a regulated environment

    • Main Duties:

  • Assists with the execution (as applicable) of quality maintenance activities.
  • Assist the maintenance, approval, and creation of quality documentation.
  • This may include Certificates of Conformance, RMAs, NCRs, etc.
  • Supports the QA/RA department with the quality onboarding of Intellijoint Surgical staff.
  • Assists with electronic document control systems, as applicable.
  • Assist in documenting and tracking employee training.
  • Support the maintenance of quality dashboards using Atlassian, Sharepoint, and/or eQMS tools.
  • Assists with the coordination and execution of quality issues (as applicable).
  • Support the internal and external Intellijoint Audit Program.
  • Review and approve product records for final release according to defined requirements and specifications.
  • Operate within all Intellijoint Surgical processes and procedures, and actively participates in continuous improvement activities.
  • Assists the submission and maintenance of regulatory documentation.

    • Skills and Experience to Enable Success:

  • Post Secondary Diploma.
  • 1-2 years relevant experience in a regulated industry.
  • Strong communication skills along with extreme attention to detail.
  • Experience working in a medical device environment (ISO 13485, FDA QSR, EU MDD/MDR, etc.) is an asset.
  • Experience working with tools such as MS Office, and Google Workspace, Dropbox, and Atlassian is an asset.

    • Why join us?

  • It is unrealistic for us to believe we will find someone who fits this position 100%
  • Strong support towards career development and growth
  • Work on innovative products that can improve surgical outcomes and enhance patient's quality of life
  • Work alongside a highly talented and driven group of team members and colleagues' organization wide
  • Work in an environment with high transparency and collaboration along with lots of fun and social activities
  • Be ok with change and share in our excitement as we scale
  • Flexibility so that you can do your best both at work and outside of it
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