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. This position reports to the VP of Global Quality.

EDUCATION, EXPERIENCE, SKILLS & QUALIFICATIONS

• Bachelors’ Degree completed, preferably Electronics and/or Engineering related.
• Minimum 5 years of electronic or related manufacturing experience.
• Minimum of 3 years of ISO9001, ISO13485 compliance experience required.
• Experience with AS9100 requirements is highly desirable.
• Previous experience in a medical device/regulated environment is highly desirable.
• Strong knowledge of standards requirement is mandatory.
• Internal and external auditing qualifications and experience is required.
• Experience in procedure writing, document management protocols is mandatory.
• Understanding of general QA processes, measurement and analytical tools is required.
• Fluent in Microsoft Word, Excel and PowerPoint.
• Good presentation skills mandatory requirement.
• Professional writing skills with experience in drafting Quality Management System procedures.
• Experience in the electronics industry is preferred.

• 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.
• Support 3rd party (ISO registrar) audits and customer audits of Vexos QMS.
• 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 internal audit schedule.
• Conduct internal audits and, as necessary, external audits.
• Validation and verification activities for both process and software (ISO13485).
• Coordinate Vexos complaints and CAPA process. Follow up on effectiveness of CAR’s and report on status.
• Prepare data analytics reports in support of Vexos Quality improvement activities.
• 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.).
• Responsible for ensuring that any outstanding audit requirements, including NCAR’s (corrective actions) are followed through in an expedient and timely manner and to the due dates specified.
• Perform other tasks as required.
• External candidates are required to provide a clear police check and satisfactory employment references.