Quality Systems Specialist - Full Time
 

SUMMARY

 

The Quality Systems Specialist reports directly to the VP, Global Quality, Vexos Markham. The Quality Systems Specialist is part of the QA group who are responsible for the Quality Management System (QMS), the Corrective and Preventative Action program (CAPA), and performance data analysis. The Quality Systems Specialist will be tasked with ongoing support, maintenance, and development of Vexos Quality Management Systems, preparation of regulatory compliance documents and will provide support to the QA team and other functional departments on Quality Management System related matters.

RESPONSIBILITIES

  • Support all aspects of Quality Management System operations within the organization.

  • Create, update, review and maintain Vexos Quality Management System procedures to ensure they reflect current business processes and needs, and meet regulatory and Quality Management System standards requirements.

  • Prepare regulatory compliance documentation for external parties. Interface with external regulatory bodies as required.

  • Provide direct support in the implementation of new Quality Management System standards.

  • Provide support for the design, execution and maintenance of quality system processes at respective departments.

  • Conduct QMS orientation training for new employees and update training for existing employees as required.

  • Maintain and develop Vexos internal audit process. Prepare reports on audit results. Maintain an internal audit schedule.

  • Conduct internal audits and, as necessary, external audits.

  • Support customer and 3rd party audits of Vexos QMS

  • Validation and verification activities for both process and software (ISO13485)

  • Coordinate Vexos complaints and CAPA processes. Follow up on the effectiveness of CAR’s and report on status. Support and participate in corrective action discussions, root cause, problem-solving as necessary.

  • Provide support for Vexos environmental and regulatory compliance activities (RoHS, Conflict Minerals, etc.)

  • Perform other tasks as required.

 

REQUIREMENTS

  • Minimum of 3 years of ISO9001, ISO13485 compliance experience. Experience with AS9100 and IATF16949 requirements would be an asset.

  • Previous experience in a medical device/regulated environment.

  • Strong knowledge of standards requirements

  • Internal and external auditing qualifications and experience

  • Experience in procedure writing, document management protocols

  • Understanding of general QA processes, measurement and analytical tools

  • Fluent in Microsoft Word, Excel and Powerpoint

  • Good presentation skills

  • Professional writing skills with experience in drafting Quality Management System procedures.

  • Experience in the electronics industry is preferred

QUALIFICATIONS

  • Bachelors Degree, preferably Electronics and/or Engineering

  • Minimum 5 years of electronic or related manufacturing experience

 

POSITION LOCATION

  • Markham, Ontario

 

As an equal opportunity employer, Vexos is committed to a diverse workforce.

Vexos™ is a trademark registered in the US Patent and Trademark Office.

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