Quality Engineer

7 days ago

Markham, Ontario, Canada Sonele Inc. Full time

The Opportunity
We are looking for a full-time candidate to fill the Quality Engineer position who will support the QA Manager and engineering team in quality engineering functions, associated with: design development, risk management, requirements, implementation, verification, drive to quality improvements and conformance to standards and regulations. This candidate will also lead the documentation development and management effort of various projects within our QMS system, for both product development and manufacturing activities.
The selected candidate will also be provided with health benefits with premiums fully paid by the company after probation period. Free parking is available on site.
Responsibilities

  • Perform problem identification, root cause analysis, resolution, loss reporting and continuous improvement
  • Design and implement methods for process control, process improvement, testing and inspection
  • Develop, execute, and analyze quality reporting measures
  • Participate in internal and external quality audits
  • Develop and manage document database for QMS, product development and manufacturing activities
  • Initiate employee on-job training and maintain training records

Qualifications

  • Degree in engineering discipline (biomedical, mechanical, electrical, materials) or related subject
  • 1-4 years' of medical industry experience
  • Strong knowledge of quality tools used in the industry
  • Analytical and quantitative approach to problem solving
  • Knowledge of ISO 13485 and ISO 9001 preferred
  • Knowledge of QMS software implementation and management is an asset

Attributes

  • Ability to work independently as well as within a team
  • Attention to details and multi-tasking
  • Ability to plan and execute quality assurance tasks within set deadlines
  • Ability to work in a fast-pace environment and work under pressure
  • Ability to troubleshoot and adapt to on-going changes to suit the needs of the team and/or customers
  • Excellent analytical and communication skills (written and oral)
  • Excellent organization and time management skills
  • Interest in biomedical or health-related industry

The above information on this job description and specification has been designed to indicate the general nature and level of work performed by employees within this job. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

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