Quality Systems Engineer

As a leader in the medical device field, our client designs and
manufactures state-of-the art products for OEMs as well as for their own
portfolio. The environment is fast-paced and offers multiple opportunities for
leadership and career growth.

Responsibilities

In this role, you will
contribute to the development of new products and sustaining product
development activities with a focus on Manufacturing Quality and Compliance in
their local facilities.

  • Review and report performance of
    the quality management system including key process indicators (KPIs)
  • Participate
    in and represent Quality Assurance in document and data control, quality
    planning, training, product recalls / advisory notices incoming and final
    inspection and lead equipment calibration
  • Participate
    in vendor selection, approval/qualification and monitoring processes.
    Follow- up on supplier issues, including notifications, corrective actions
    and supplier audits. Maintain supplier files.
  • Review and
    disposition non-conforming material, lead and facilitate MRB board
    activities.
  • Provide
    analysis, support, follow-up, effectiveness verification and close out of
    CAPAs.
  • Support creation of technical
    files and sign-off for relevant documentation
  • Participate in product design
    control activities for new and sustaining product development efforts,
    including documentation review and changes via formal change control.
  • Support risk
    analysis activities, including hazard analyses, design and process FMEAs
  • Support
    Process/Design Validation/Verification activities, including software
    validation and IQ/OQ/PQ activities
  • Support
    Engineering in the creation, review and approval of DMR, DHR, routers,
    bills of material, and specifications for in- house/ external
    manufacturing.
  • Conduct
    Internal Audits of the Quality System
  • Prepare for
    and participate in audits by external organizations, such as FDA, ISO etc.

 

Requirements

  • Bachelor’s
    degree in scientific, biomedical, or engineering discipline
  • 5 years
    minimum of experience in Medical Device Quality Assurance
  • Experience
    performing internal quality audits and supplier audits to ISO 13485
  • Solid
    understanding of applicable regulations, including FDA 21 CFR Part 820,
    ISO 13485, Health Canada MDD’s, European MDR’s
  • Experience
    with single-use and reusable medical devices manufactured in a Class 7
    controlled manufacturing environment and electro-mechanical devices
    preferred

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